The pursuit of a cure for deep venous valvular reflux—long considered to be the “holy grail” of deep venous disease—is underway, with new technologies set to address a longstanding unmet clinical need across the globe.
Chronic venous disease affects nearly...
Nicolas J Mouawad (McLaren Health System, Bay City, USA) urges vascular surgeons to “get out of their comfort zone” and become more involved in pulmonary embolism (PE) care.
With over one million cases of deep vein thrombosis (DVT) and/or PE...
The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities. The recommendations,...
Venous News 15—September 2023
Issue highlights:
Sixty years in the making: Deep venous valve technologies set to address “large unmet need worldwide”
Spring/summer 2023 conference round-up: Highlights from the Charing Cross (CX) Symposium, International Vein Congress (IVC), European Venous Forum (EVF)...
In this issue:
Sixty years in the making: Deep venous valve technologies set to address “large unmet need worldwide”
Spring/summer 2023 conference round-up: Highlights from the Charing Cross (CX) Symposium, International Vein Congress (IVC), European Venous Forum (EVF) and more
...
In this issue:
Sixty years in the making: Deep venous valve technologies set to address "large unmet need worldwide"
Spring/summer 2023 conference round-up: Highlights from the Charing Cross (CX) Symposium, International Vein Congress (IVC), European Venous Forum (EVF) and...
“The median thrombus age of DVT patients treated in our centre is 14 days – says Dr Andrew Wigham from Oxford University Hospitals. – We know that traditional treatment options such as thrombolytics and other thrombectomy devices are less...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new approved bodies to increase the country’s capacity to certify medical devices.
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling...
Medtronic has announced that an updated ClosureFast radiofrequency ablation (RFA) catheter in a lower 6Fr profile is now available in the USA following 510(k) clearance from the US Food and Drug Administration (FDA). The ClosureFast procedure is intended to...
“Everything depends on the symptoms,” Aleksandra Jaworucka-Kaczorowska, of the Center of Phlebology and Aesthetic Medicine and the Center of Surgery, Gynaecology and Obstretics in Gorzów Wielkopolski, Poland, stresses in an interview on pelvic venous incompetence with Venous News.
“Your decision...
In a recently published study, dedicated venous stents performed well through pregnancy and postpartum, and a protocol including the use of low-dose antiplatelets in combination with anticoagulation at either a prophylactic or therapeutic dose depending on the patient’s risk...
Researchers report that inferior vena cava (IVC) filter placement position relative to the level of the most inferior renal vein was not associated with differences in IVC thrombosis in a recent single-centre cohort study.
Additional key findings from the study...
This advertorial, sponsored by Inari Medical, is only available in selected countries and geographies.
During a recent webinar hosted by Inari Medical, a multidisciplinary group of physicians focused in on how to select eligible patients for the endovascular treatment of...
This advertorial is sponsored by Inari Medical
“We need to eliminate symptoms as fast as possible—it is not OK just to make things a little better,” says Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany), setting out why intervention...
Five-year results of the LAMA randomised controlled trial (RCT) show that both mechanochemical ablation (MOCA) and modern endovenous laser ablation (EVLA) technology are associated with low procedural and post-procedural pain, while clinical outcomes in the short and medium term...
The Society of Interventional Radiology (SIR) has published a position statement offering recommendations on the management of chronic iliofemoral venous obstruction with endovascular placement of metallic stents. The statement, published online in the Journal of Vascular and Interventional Radiology, is a...
Uncertainty underlying the magnitude of risk posed by long distance air travel in venous thromboembolism (VTE) patients has created the need for a deeper, systematic dive into the guidelines and resources providers should be turning to when managing their...
In an interview with Venous News at this year’s Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Raghu Kolluri (Columbus, USA) outlined the “vast list” of options that are now available for the treatment of patients who require...
Why is clot removal crucial for patients suffering from DVT? What are the major benefits of a lytic-free thrombectomy? Watch Michael Lichtenberg (Arnsberg, Germany) present the outcomes of the Arnsberg ClotTriever Study which confirms the safety and efficacy of...
Despite being considered “generally safe”, cyanoacrylate can cause local reactions in up to 25% of patients, disproportionately affecting women, Asian race and thin patients with a body mass index of <22. This was the conclusion drawn by Eduardo Silva...
Delivering results and recommendations from a systematic review and meta-analysis of novel oral anticoagulants (NOACs) versus low molecular weight heparin (LMWH) in the prevention of venous thromboembolism (VTE) recurrence in cancer patients, Patricia Noreen Bueno (St Luke’s Medical Center,...
Biolitec recently announced that it has extended its ELVeS Radial laser system for the minimally invasive laser treatment of insufficient veins by two further new developments.
The ELVeS Radial 2ring Pro laser fibre is capable of removing even highly...
A study of two risk assessment models (RAMs) for predicting the bleeding risk in patients considered for pharmacologic prophylaxis to prevent venous thromboembolism (VTE) has found that though an increasing risk score correlated with higher bleeding rates, both models...
In a second compassionate use case, interventional vascular surgeon Stefan Stalhoff of Klinikum Hochsauerland (Arnsberg, Germany) used VeinWay's Traversa for venous recanalization to save a patient's arm, with supervision by VeinWay scientific advisory board member Michael Lichtenberg. The patient had...
Inari Medical today announced the launch of two new purpose-built products, the RevCore thrombectomy catheter, and the Triever16 Curve catheter.
According to a company press release, RevCore is the first mechanical thrombectomy device designed to address venous in-stent thrombosis, an...
Gore has announced that the first US patient has been enrolled in a prospective, non-randomised, multicentre, single-arm study with five-year follow-up to evaluate the investigational Gore Viafort vascular stent for the treatment of symptomatic iliofemoral venous obstruction.
The first US...
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design and conduct of clinical trials.
In a statement, the regulator said that the updates are intended...
Medtronic has announced that Ken Washington has been appointed chief technology and innovation officer.
Washington joins Medtronic from Amazon where he served as vice president and general manager of consumer robotics, and will lead technology development across industries including robotics,...
“I see a future where this technology may be used to treat people early and avoid the devastating long term consequences of venous insufficiency” Ramon Varcoe (Sydney, Australia) opined in a CX Vascular Live discussion with Erin Murphy (Charlotte,...
Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Bolt 7, which the company claims is the most advanced and powerful arterial thrombectomy system on the market.
Lightning Bolt 7 introduces a new method...
Speaking on the FLAME, FLASH and PEERLESS trials that each collected data on the FlowTriever (Inari Medical) device for the treatment of pulmonary embolism (PE), Ripal Gandhi (Miami Cardiac & Vascular Institute & Miami Cancer Institute, Miami, USA) elaborated...
Presenting “remarkable results” from the JETi registry—a prospective, multicentre, observational study which collected real-world data on the safety, performance and clinical benefits of the Jeti peripheral thrombectomy system—speaker Mahmood K Razavi (Children’s Health of Orange County, Orange, USA) relayed...
Steven Abramowitz (Washington DC, USA) explains the significance of the CLOUT registry—the only registry capturing data on mechanical thrombectomy in deep venous thrombosis (DVT). CLOUT confirms excellent safety results and effectiveness of the ClotTriever system in real-world DVT patients....
This article was provided by the American Vein & Lymphatic Society.
The UIP 2023 World Congress (17–21 September, Miami Beach, USA) will bring professionals from different countries and regions to share knowledge, exchange ideas, and discuss the latest advances in...
Six-month outcomes from the FLASH registry have shown that patients with pulmonary embolism who were treated with mechanical thrombectomy showed significant improvement in symptoms, quality of life and cardiac functions.
The findings were presented as late-breaking clinical research at the...
A recent study concludes that non-thrombotic iliac vein lesion (NIVL) patients have better primary patency after venous stenting than patients with venous thrombotic disorders. Olivier Espitia (CHU de Nantes, Nantes, France) and colleagues report this main finding from a...
Venous disease care has a problem with optics in the context of growth in the number of venous procedures and the spectre of inappropriate care, the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) heard.
The conversation thread...
The deep venous consensus update session at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) covered a range of key topics in the field, including issues associated with pelvic venous lesions.
The session opened with a series...
A recent multicentre, prospective study has found that stent deformations are greater in the common iliac vein with higher levels of hip flexion, as well as in iliofemoral veins with hyperextension at the superior ramus of the pubis. The...
This advertorial is sponsored by Merit Medical.
The ClariVein OC endovenous occlusion catheter (Merit Medical) is associated with a good occlusion rate, comparable with other techniques including thermal, without major complications. This is according to a five-year Italian experience with...
Akura Medical announced today it has initiated its first-in-human clinical study of the Akura mechanical thrombectomy platform. A press release notes that the Akura platform is a low-profile solution designed to easily access and efficiently remove large-volume, mixed-morphology clots,...
Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency (CVI). The patient was treated by principal investigator Mauricio Alviar (Clinica de...
“Superficial venous treatments have come a long way in the last 20 years,” Manj Gohel (Cambridge, UK) tells Venous News, before outlining the key aims of the VenaSeal Spectrum programme—which includes three studies (two randomised and one prospective observational...
The Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application for the VEINRESET multicenter pivotal study that will evaluate Sonovein high-intensity focused ultrasound (HIFU) treatment for varicose veins, it has been announced.
Antonios Gasparis, MD, director...
The CX 2023 Venous & Lymphatic programme it set to be a “highlight” of this year’s meeting, CX co-chair and executive board member Erin Murphy (Sanger Heart and Vascular Institute, Atrium Health, Charlotte, USA) tells Vascular News.
This year’s programme...
UK-based medical device manufacturer Sky Medical Technology today announced the International Wound Journal has published a multicentre randomised self-controlled trial (RCT) from the company.
The study compared standard of care with and without the Geko device in patients with hard-to-heal venous...
W L Gore & Associates (Gore) has announced that the first US patient has been enrolled in a prospective, non-randomised, multicentre, single-arm study with five-year follow-up to evaluate the investigational Gore Viafort vascular stent for the treatment of symptomatic...
Recruitment proved to be a major challenge for the STEVECO (Stent versus conservative treatment in patients with deep venous obstruction) randomised controlled trial (RCT), prompting discussion on how best to randomise patients in future trials, the ethics of doing...
A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)—an executive agency of the UK Department of Health and Social Care (DHSC)—to help bring innovative new medicines and medical technologies to UK...
An analysis of venous stent usage trends in the USA from 2014 to 2021 showed a “significant increase” in stents per day placed over time, despite high-profile recalls of two dedicated venous stents from the market.
Those were among the...
The 2023 annual meeting of the American Venous Forum (AVF; 22–25 February, San Antonio, USA) heard the final results from the first US trial of the emerging varicose vein treatment, Sonovein echotherapy (Theraclion), with data showing a 100% technical...
Robert A Lookstein, who is executive vice chair, Diagnostic, Molecular and Interventional Radiology at the Icahn School of Medicine at Mount Sinai Hospital (New York, USA) today presented the results of a subanalysis of Thrombolex’s National Heart, Lung and...
Speaking to Venous News at VEITHsymposium 2022 (15–19 November, New York, USA) Armando Mansilha (Porto, Portugal) answers the “challenging question” of how to best approach selecting an appropriate care pathway for patients with superficial venous disease. Offering a range...
The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).
Producers of medical devices will have until 31 December 2027 for higher risk...
Large bore mechanical thrombectomy with the FlowTriever system (Inari Medical) in patients with high-risk pulmonary embolism (PE) was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes compared to other contemporary treatments, data presented at the...
Among 61 high-risk pulmonary embolism (PE) patients followed through to the 30-day visit in the US cohort of the FLASH registry, no mortalities were recorded, while at 48 hours post-treatment with the FlowTriever mechanical embolectomy system (Inari Medical), likewise,...
Viz.ai has announced it will use its Viz Recruit platform to optimise patient enrolment for the National Institutes of Health (NIH)-funded Pulmonary embolism—thrombus removal with catheter-directed thrombolysis (PE-TRACT) clinical trial.
The company claims that PE-TRACT will be the most rigorous...
In a first-in-human, compassionate-use case approved by the US Food and Drug Administration (FDA), University of Michigan Health (Ann Arbor, USA) interventional radiologists David M Williams and Minhaj S Khaja successfully used VeinWay's Traversa for venous recanalisation to save...
Interim one-year outcomes from the multicentre, prospective, single-arm CLOUT registry investigating use of the ClotTriever thrombectomy system (Inari Medical) in all-comer patients with deep vein thrombosis (DVT) demonstrated that 93.5% of limbs had flow present, 97.1% were compressible and...
Researchers in Colombia behind the first-in-human study of a novel bioprosthetic venous valve designed to treat chronic venous insufficiency (CVI) reported three-year results among the eight remaining patients during the 2023 annual meeting of the American Venous Forum (AVF;...
Stephen Black (London, UK) talks to Venous News about the key 36-month results from the ABRE study, which evaluated the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with...
Few adverse events are connected to the use of inferior vena cava (IVC) filters to help prevent deep vein blood clots from developing into pulmonary embolisms (PEs), according to the findings of the Predicting the Safety and Effectiveness of...
In a prospective study of patients undergoing great saphenous vein (GSV) ablation, researchers found no correlation between maximum reflux time and symptom severity as measured by Venous clinical severity score (VCSS).
Authors Damianos G Kokkinidis (Yale University, New Haven, USA)...
NOTE: This video is ONLY available to watch in selected countries and geographies
Iliac side branch devices (ISBs) are “gamechangers in infrarenal therapy of abdominal aortic aneurysms (AAAs),” Mario Lescan (Tübingen, Germany) tells Vascular News. Lescan states that ISBs “allow...
Prominent venous disease experts discuss venous stenting, appropriate care, and the pursuit of refined data and better education in a space where part of the problem involves practitioners moving “freely from being able to do arterial intervention and suddenly...
Theraclion has announced the results of the first Sonovein trial in the USA, which the company describes as a "major milestone" towards receiving US Food and Drug Administration (FDA) approval and accessing the US varicose veins market.
Theraclion reports a...
Inari Medical has announced that the first patient has been enrolled in DEFIANCE, a prospective randomised controlled trial (RCT) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only....
Today, Penumbra announced the US Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system.
"Lightning Flash features Penumbra's novel Lightning intelligent aspiration technology, now with dual clot detection algorithms," the company notes in a...
Koya Medical recently announced the appointment of Thomas Maldonado (New York University Medical Center, New York, USA) as chief medical officer and a member of the company's clinical advisory board.
A press release notes that Maldonado has been one of New York...
An evaluation of the Vascular Quality Initiative’s (VQI) Varicose Vein Registry (VVR) carried out by the Midwestern Vascular Surgical Society (MVSS) has found women to benefit similarly from endovenous ablation as men, but experience fewer complications post-procedure.
The MVSS...
A meta-analysis is first to report the pooled risk of post-thrombotic syndrome (PTS) after isolated distal deep vein thrombosis (DVT). Researchers revealed a one in five risk of long-term PTS after isolated distal DVT, with one in 50 patients...
Corindus has been rebranded to Siemens Healthineers Endovascular Robotics and will sit as a dedicated business within the Advanced Therapies area of Siemens Healthineers, the company has announced.
This brand unification is the final step of the company integration process...
Boston Scientific has announced that it will make a partial offer to acquire a majority stake, up to a maximum of 65%, of shares of Acotec Scientific, a Chinese medical technology company that offers solutions designed for a variety...
Head-to-head observational analysis showed Xarelto as effective in treating cancer-associated thromboembolism (CAT) as apixaban.
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced observational data from eight years of clinical practice showing that the oral Factor Xa inhibitor Xarelto...
Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) will be put forward in early 2023.
Kyriakides informed health ministers from the EU’s...
The Society for Vascular Surgery (SVS) has published an update to the SVS/American Venous Forum (AVF) 2011 clinical practice guideline on the care of patients with varicose veins. This guideline update was developed in collaboration with the AVF and...
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion for ‘more freedom of action in the procurement of medical products for supply of the...
Positive long-term, three-year observational data from a cohort of patients that participated in the previously concluded VenoValve (Envveno Medical) first-in-human clinical trial were recently presented at the VEITHsymposium 2022 (15–19 November, New York, USA).
Principal investigator Jorge Hernando Ulloa (University of...
This advertorial is sponsored by Bentley.
Launched in July 2020, the BeYond Venous self-expanding stent system (Bentley InnoMed GmbH) now has early clinical data and expert experience to support its use in venous interventions. In what Michael Lichtenberg (Arnsberg Vascular...
The Society of Interventional Radiology (SIR) published a position statement deeming endovascular thrombus removal “an acceptable treatment option in selected patients with acute iliofemoral deep vein thrombosis .” The position statement is published online on the Journal of Vascular and...
A retrospective review, presented as a late-breaking clinical trial at The VEINS (Venous Endovascular Interventional Strategies) 2022 (30–31 October, Las Vegas, USA), indicates that single-session thrombectomy for the treatment of iliofemoral deep vein thrombosis (DVT) is associated with reduced...
Two datasets presented during the late-breaking clinical trials session at The VEINS (Venous Endovascular Interventional Strategies) 2022 (30–31 October, Las Vegas, USA)—the latest results from CLOUT and a propensity score-matched analysis of CLOUT versus ATTRACT—bolster the evidence base for...
Gerd Grözinger (Tübingen, Germany) chats with Bernhard Gebauer (Berlin, Germany) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) about some of the difficulties associated with treating patients with pulmonary embolism...
W L Gore & Associates (Gore) today announced the first implants of its investigational Gore Viafort vascular stent as part of the recently initiated Gore Viafort device pivotal clinical study for the treatment of inferior vena cava (IVC) occlusive...
Theraclion announced at the American Vein and Lymphatic Society (AVLS) 2022 annual meeting (13–16 October, New Orleans, USA) that the final patient has been enrolled and treated in the first US study of the company's Sonovein solution for varicose...
Medtronic has announced the 36-month final results from the ABRE clinical study. The purpose of the ABRE clinical study was to evaluate the safety and effectiveness of the company's Abre venous self-expanding stent system, intended for the treatment of...
Tilting or hooking occurred significantly less often in the process of retrieving the Denali inferior vena cava (IVC) filter (BD) than with the Option IVC device, a retrospective review at a tertiary care centre has established.
The research team behind...
John White (Chicago, USA) talks to Venous News at this year’s European Society for Vascular Surgery annual meeting (ESVS 2022; 20–23 September, Rome, Italy), about a procedure that is designed to help treat women who suffer from chronic pelvic...
Results of the FLASH registry demonstrate the “excellent safety profile” of the FlowTriever system (Inari Medical) in 800 “real-world” patients. This is according to Catalin Toma (University of Pittsburgh Medical Center, Pittsburgh, USA), who presented outcomes for the full...
Penumbra and Asahi Intecc, a Japanese medical device manufacturer, announced that they will collaborate to introduce Penumbra’s Indigo aspiration system into the Japanese market upon regulatory approval.
“By bringing together our newest innovations with Asahi’s leadership and expertise in the...
Thrombolex today presented the final results of its National Institutes of Health (NIH)-sponsored RESCUE trial at TCT 2022 (16–19 September, Boston, USA).
This investigational device exemption (IDE) trial demonstrated that pharmacomechanical catheter-directed thrombolysis (PMCDT) therapy using the Bashir endovascular...
The International Consortium for Health Outcomes Measurement (ICHOM) venous thromboembolism (VTE) working group has developed a standard set of outcome measures for patients with VTE. The consensus recommendation—published in the September edition of The Lancet Haematology—is designed to “facilitate...
Bentley today announced that it has acquired the rights of the GoBack catheter from Upstream Peripheral Technologies.
“The acquisition of the GoBack catheter marks the start of inorganic growth for Bentley,” said Sebastian Büchert, Bentley's CEO. “We launched our first...
This advertorial, sponsored by Inari Medical, is only available in selected countries and geographies.
“I am finally very confident I have a device that takes out all the thrombus,” stated Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany)...
Viz.ai recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for an automated right ventricle (RV)/left ventricle (LV) ratio algorithm, a new component of the Viz pulmonary embolism (PE) solution.
According to a company press release,...
Andrew Wigham (Oxford, UK) and Rick De Graaf (Friedrichshafen, Germany) discuss the current state of deep vein thrombosis (DVT) treatment at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany), with both noting that “a massive problem” in...
A multicentre, prospective, randomised study published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (JVS-VL) showed that inspiratory muscle training (IMT), in addition to compression therapy, modified disease activity in patients with chronic venous insufficiency (CVI) with...
Treatment of critically ill COVID-19 patients with full-dose anticoagulation lowers the risk of venous and arterial clotting complications by 44% compared with the standard dose, according to late breaking research presented in a Hot Line session at ESC Congress...
Inari Medical has announced planned enrolment of the DEFIANCE randomised controlled trial (RCT), which is designed to compare the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only.
The trial will...
Ramona Gupta (Northwestern University, Chicago, USA) addresses the issue of recurrent varicose veins, highlighting in particular the “multiple tools” now at physicians’ disposal to treat the problem.
Superficial venous insufficiency and varicose veins affect approximately 23% of adults worldwide. Treatments...
New data indicate that venous stent failure “may be predicted by low peak flow velocity and post-thrombotic changes in inflow veins” and that endovascular venous stenting for chronic outflow obstructions is an “efficacious and safe” treatment in selected patients.
These...
A new study highlights key differences in clinical features and comorbidities, as well as short-term and also long-term outcomes for patients with distal deep vein thrombosis (DVT) versus proximal DVT. The findings were recently published in JAMA Cardiology.
The differences...
Postprocedural compression of one to two weeks after superficial venous incompetence (SVI) treatment is associated with reduced pain compared with a shorter duration. This is according to a study published in the August edition of the British Journal of...
This week Inari Medical announced that chief operating officer Drew Hykes will succeed Bill Hoffman as chief executive officer, effective 1 January 2023. Hykes will join Inari’s board of directors and Hoffman will also continue to serve on the...
Based on the findings of a multicentre, randomised controlled trial, researchers have concluded that a new iliac vein stent—the Venastent (Tianhong)—provides a “safe and effective” endovascular treatment option for non-thrombotic iliac vein lesions (NIVLs) and is “as efficient as”...
In a prospective, controlled clinical trial of deep vein thrombosis (DVT) triage using artificial intelligence (AI)-guided software simulating compression ultrasonography, lead investigator Efthymios Avgerinos (University of Athens, Athens, Greece) and colleagues demonstrated a high sensitivity and specificity in DVT...
Thrombolex has announced that its board of directors has named Michael Cerminaro chief executive officer (CEO) effective 13 July 2022, the date of the company’s most recent quarterly board meeting.
The company advises Cerminaro will also retain his current title...
Biolitec recently announced the launch of a new addition to its ELVeS Radial family—the ELVeS Radial 2ring Swift fibre. According to a company press release, both larger truncal veins and smaller side branches and perforating veins can be treated...
In a new subgroup analysis of the EXTRACT-PE trial, the Indigo aspiration system (Penumbra) was effective at improving clinical outcomes for submassive pulmonary embolism (PE) patients regardless of emboli location. In addition, clot burden was significantly reduced in both...
I-Vasc, which has developed and CE marked its percutaneous Velex system to treat chronic venous insufficiency (CVI), has announced that Velex has entered clinical use, with the first two cases performed last week in Milan, Italy, at the Policlinico...
Despite greater comorbid conditions, patients with obesity benefited as much as patients with normal body mass index (BMI) from iliac vein stent placement for proximal venous outflow obstruction (PVOO) in a study from a research group in New York....
Optimed recently announced the presentation of two prospective, multicentre trials evaluating the performance and effectiveness of their venous stent systems at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany).
The TOPOS trial two-year results for the Sinus-Obliquus stent...
Ten-year follow-up of a randomised controlled trial (RCT) has shown no clear long-term advantage of endovenous laser ablation (EVLA) with a 980nm wavelength and bare-tip fibre over high ligation and stripping of the great saphenous vein (GSV) under local...
Patients who have suffered from a first episode of unprovoked venous thromboembolism (VTE) have an eight times higher risk of recurrence if they stop treatment after repeated negative D-dimer tests, instead of continuing with low-dose anticoagulant (apixaban), according to...
RapidAI announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Rapid PE Triage & Notification product for fast identification and communication of suspected central pulmonary embolism (PE).
According to a company press release,...
This advertorial is sponsored by Merit Medical. A downloadable version can be found here.
In this case series, Michael Tal (Jerusalem, Israel) explains how the ClariVein OC device (Merit Medical) offers a safe treatment option for venous leg ulcers.
Venous...
This advertorial is sponsored by Merit Medical.
In this case series, Michael Tal (Jerusalem, Israel) explains how the ClariVein OC device (Merit Medical) offers a safe treatment option for venous leg ulcers.
This advertorial is sponsored by Cook Medical. A downloadable version can be found here.
The Zilver Vena venous self-expanding stent system (Cook Medical) is associated with high rates of patency by ultrasound, freedom from clinically-driven reintervention and clinical improvement among...
This advertorial is sponsored by Cook Medical.
The Zilver Vena venous self-expanding stent system (Cook Medical) is associated with high rates of patency by ultrasound, freedom from clinically-driven reintervention and clinical improvement among various challenging subgroups, according to newly released...
BD recently announced that its Venovo venous stent is back on the US market following a recall last year.
In 2019, the company reported that the US Food and Drug Administration (FDA) had granted premarket approval for the Venovo venous...
In an initial cohort of patients enrolled in the CLEAR-DVT study, contemporary venous intervention resulted in an open vein, which reduced post-thrombotic syndrome (PTS). This is the main concluding finding of a Podium 1st presentation delivered by Mitchell Silver...
Magneto Thrombectomy Solutions (Magneto), a medical devices company developing thrombectomy solutions for the treatment of ischaemic stroke and pulmonary embolism, presented successful first-in-human (FIH) results showing safety and feasibility of the eTrieve system, a catheter based on electric fields...
To combat the “overtreatment problem” in the appropriate care of venous disease, “a concerted, complex, multimodal effort” is required from specialists across disparate parts of the world.
That was the conclusion delivered by Manjit Gohel (Cambridge University Hospitals, Cambridge, UK)...
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities as chief clinical and regulatory officer, aligning and integrating the company's scientific, medical, clinical research...
Koya Medical recently announced the US commercial availability of its Dayspring active compression system for the treatment of lymphoedema and venous diseases in lower extremities. The company also announced that the Centers for Medicare & Medicaid Services (CMS) issued...
Penumbra has announced that its Indigo aspiration system with Lightning 7 and Lightning 12 have secured CE mark and are now commercially available in Europe. Both technologies are part of Penumbra’s Indigo aspiration system—now with Intelligent Aspiration for mechanical...
Looking to the future, genetic testing may play a role in guiding the intensity of therapeutic interventions and preventive strategies in patients with venous disease. This finding comes from a case-control study on the clinical implications of genetic variation...
I-Vasc, developer of the Velex device with its empty vein ablation (EVA) technology for the treatment of chronic venous insufficiency (CVI), has announced the completion of its Series A financing round.
In addition to the €750,000 tranche raised in the...
A study from Sweden published by The BMJ recently finds an increased risk of deep vein thrombosis (DVT) up to three months after COVID-19 infection, pulmonary embolism (PE) up to six months, and a bleeding event up to two months.
The...
Cordis has announced a strategic investment venture that will expand the scope of the global cardiovascular technology company into the venous thromboembolism (VTE) market with a strategic investment in Endovascular Engineering (E2), a developer of next-generation thrombectomy devices to...
Anticoagulants alone are associated with a high rate of resolution of pulmonary embolism (PE) in patients with acute PE and COVID-19 infection. This was the main concluding finding of a study published in the Journal of Vascular Surgery: Venous...
Sky Medical Technology has announced it has achieved further US Food and Drug Administration (FDA) 510(k) clearance to market the new (W3) geko device variant, for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous...
Bert van Meurs, the chief business leader for Image Guided Therapy with Royal Philips, speaks to Venous News following the company’s acquisition of Vesper Medical in December last year. He details how the procurement will further expand Philips’ portfolio...
In a secondary analysis of the SUNSET sPE randomised controlled trial, Efthymios Avgerinos (University of Pittsburgh Medical Centre, Pittsburgh, USA) and colleagues found differences in biomarker levels in response to treatment with catheter-directed therapies compared to anticoagulation alone. These...
Venous stenting was a hot topic on the agenda of the recent American Venous Forum (AVF) annual meeting (23–26 February, Orlando, USA). Catching the audience’s attention, one presenter highlighted a head-to-head study of dedicated versus non-dedicated stents.
“Iliofemoral venous obstruction when...
Medtronic has announced that it has entered into a contract with Vizient to add Touch Surgery Enterprise, an AI-powered surgical video management and analytics platform for the operating room (OR), to Vizient's offerings.
In a press release, Medtronic said that...
Vascular Breakthroughs and Vascular Care Connecticut have announced the first New England enrolment into the novel DEXTERITY clinical trials of local anti-inflammatory therapy to improve outcomes of deep vein thrombosis (DVT) therapy.
Paul Gagne and the research team at Vascular...
Iliac vein stents tolerate a gravid uterus well and a possible future pregnancy should not contraindicate their usage in the treatment of pelvic venous insufficiency (PVI), according to a recent press release.
According to lead author Peter Pappas (Centre for...
In patients with chronic venous disease (CVD) and associated ipsilateral limb reflux, iliac vein stenting was shown to improve the prevalence of reflux and severity in the long term. This is the main concluding finding of a single-centre retrospective...
An emerging endovenous valve formation system designed to treat patients with chronic venous insufficiency (CVI) with evidence of deep venous reflux has demonstrated continual improvement since US investigators started performing clinical cases with the device 18 months ago, according...
This year’s venous and lymphatic programme at the Charing Cross (CX) International Symposium 2022 (26–28 April, London, UK, in person and virtual) will cover various challenges in the field—ranging from appropriate care conundrums to venous challenges in relation to...
Six-month outcomes from the ongoing CLOUT registry demonstrate the “safety and efficacy” of the ClotTriever thrombectomy system (Inari Medical) in a real-world deep vein thrombosis (DVT) population regardless of clot chronicity level, the 2022 annual meeting of the American...
Charing Cross (CX) chair Roger Greenhalgh welcomes the vascular community to this year's symposium, due to be held 26–28 April in London, UK, and virtually. To read the preliminary programme and register visit cxsymposium.com.
Envveno Medical announced positive 30-month data from the first-in-human trial of the VenoValve bioprosthetic potential venous valve replacement during the 2022 American Venous Forum (AVF; 23–26 February, Orlando, USA).
The results showed that VenoValve recipients—now an average of 30 months...
PolarityTE has announced results from a multicentre randomised controlled trial (RCT) evaluating treatment of venous leg ulcers (VLUs) with its investigational product SkinTE plus standard of care versus standard of care alone. The trial met the primary endpoint of...
Cardiovascular Systems Inc (CSI) recently announced it has partnered with Innova Vascular (Innova) to develop a full line of novel thrombectomy devices.
According to a press release, CSI intends to acquire and commercialise novel thrombectomy devices from Innova targeting peripheral vascular...
In patients with concurrent deep venous obstruction (DVO), superficial venous reflux (SVR) ablation is suggested to be safe, according to a recent systematic review. The authors of the study published in the Journal of Vascular Surgery: Venous and Lymphatic...
Direct oral anti-coagulants (DOACs) work just as well to prevent future clots as warfarin and are less likely to result in major bleeding after a cerebral venous thrombosis (CVT) stroke, according to preliminary late-breaking science presented at the American...
Inari Medical has announced that the first patient has been enrolled in PEERLESS—a prospective, randomised controlled trial (RCT) comparing the outcomes of patients with intermediate-high risk pulmonary embolism (PE) treated with the FlowTriever system versus catheter-directed thrombolysis (CDT).
The first...
Acera Surgical has announced its first patient enrolment in a multicentre, head-to-head clinical study evaluating Restrata for the treatment of non-healing venous leg ulcers (VLUs). William Marston (University of North Carolina School of Medicine, Chapel Hill, USA) is the...
Royal Philips has announced an update to its handheld ultrasound platform—Lumify—adding Pulse Wave Doppler technology to expand the haemodynamic assessment and measurement capabilities of the system.
In a press release, Philips said that the new functionality would enable clinicians to...
Koya Medical has announced the close of a US$26 million Series B financing. The round was led by 3x5 Partners, along with new investors including Asahi Kasei Ventures, Cadence Healthcare Ventures, and existing investors Arboretum Ventures and Scientific Health...
Stent migration following treatment of acute iliofemoral thrombus or venous obstruction is “rare but may be underreported”, with the majority of reported cases being shorter and smaller diameter stents. This is the main concluding finding of a systematic review...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As per an FDA press release, the finalised version of the first of these two guidance...
A retrospective study of 1,223 iliac vein cases performed in three office-based laboratories (OBLs) shows a major complication rate of 0.41%, suggesting these procedures are safe and well-tolerated in this setting.
“Because OBLs are not regulated to the same degree...
A new study reports that watching TV for four hours a day or more is associated with a 35% higher risk of venous thromboembolism (VTE) compared with less than 2.5 hours. The research is published today in the European...
Deep venous stenting with the Blueflow venous stent (Plus Medica) offers favourable primary patency, and is associated with significant continued improvement of symptom severity in patients with obstructive chronic venous disease (CVD) out to 12 months. Michael Lichtenberg (Vascular...
The Abre venous stent (Medtronic) remains safe and effective for the treatment of iliofemoral venous obstructive disease out to 24 months. This is according to Erin Murphy (Sanger Heart and Vascular, Atrium Health, Charlotte, USA), who presented the latest...
Thrombolex has announced positive results from the prespecified interim analysis of the first 62 evaluable pulmonary embolism (PE) patients enrolled in the investigational RESCUE trial.
RESCUE is a prospective multicentre, single-arm pivotal trial evaluating patient outcomes after treatment of acute...
The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limb to update its 2015 recommendations. The document, authored by Marianne G De Maeseneer (Erasmus...
The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limbs to update its 2015 recommendations. The document, authored by Marianne G De Maeseneer (Erasmus...
Mercator MedSystems has recently announced that the DEXTERITY trials research has begun under a technology transfer grant for approximately $300,000 funded by the National Institutes of Health (NIH). Preclinical research performed using the grant resources aims to demonstrate mechanistic...
Akura Medical has announced the closing of its $25M Series A1 financing, which will be used to support the development of its next-generation thrombectomy device.
The financing was led by Cormorant Asset Management, with participation from The Capital Partnership (TCP), PA MedTech...
Venous care in the UK is in a “sorry state at the moment”, Zola Mzimba (Derry, UK) tells Venous News. This is in part down to COVID-19 which has driven a continued rise in waiting lists and patient assessments. However,...
MolecuLight announced today that SWK Holdings has provided US$10 million structured debt to support MolecuLight’s global commercial expansion.
SWK Holdings Corporation is a life science focused specialty finance company catering to small- and mid-sized commercial-stage companies through the creation of...
The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the US Food and Drug Administration (FDA) has approved two paediatric indications for Xarelto (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent...
Vesper Medical recently announced the completion of enrolment in its pivotal study—VIVID (Venous stent for the iliofemoral vein investigational clinical trial using the Vesper Duo venous stent system).
VIVID enrolled its 160th patient earlier this month, marking completion of enrolment...
Sky Medical Technology recently announced US Food and Drug Administration (FDA) 510(k) clearance to market the Geko device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischaemia.
According to Sky Medical, the...
Royal Philips has announced US Food and Drug Administration (FDA) de novo clearance for the Philips inferior vena cava (IVC) filter removal laser sheath—CavaClear—to remove an IVC filter when previous methods of removal have failed.
The Philips CavaClear IVC filter...
Royal Philips today announced that it has signed an agreement to acquire Vesper Medical, a US-based medical technology company that develops minimally-invasive peripheral vascular devices.
Vesper Medical will further expand Philips’ portfolio of diagnostic and therapeutic devices with an...
InterVene recently announced that it has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for the company’s BlueLeaf endovenous valve formation system.
According to the company, BlueLeaf is the first catheter-based solution developed for deep vein...
A systematic review and meta-analysis published online in the European Journal of Vascular and Endovascular Surgery has suggested that, following endovenous thermal ablation of varicose veins, compression stockings only slightly reduce pain with no significant improvement to quality of...
The rate of follow-up after an incomplete and negative lower extremity venous duplex ultrasound (I/N LEVDUS) has been shown to increase following a specific recommendation for follow-up in the ultrasound report. This was the main concluding finding of a...
Catherine Arundel (York, UK) talks to Venous News at the UK Vascular Societies’ Annual Scientific Meeting (VSASM 2021; 1–3 December, Manchester, UK) about the VenUS-6 trial—a randomised controlled trial which aims to recruit and randomise 675 people with venous...
BD announced today it has acquired Venclose, a provider of solutions for the treatment of chronic venous insufficiency (CVI).
"We are committed to setting a new standard of excellence for people living with venous disease, and that starts with providing...
A worldwide study led by McMaster University in Hamilton, Canada, has shown that milvexian can be used to prevent venous blood clots with minimal side-effects.
Milvexian is unique in that it works by targeting factor XIa, a clotting enzyme that...
Viz.ai has announced the US commercial launch of its AI-powered modules for pulmonary embolism and aortic disease. Debuting at VEITHsymposium 2021 (16–20 November, Orlando, USA), the new modules allow for faster clinical decision-making and improved care coordination for patients suffering from...
RD Global & Invamed recently announced that five-year results of a comparison between cyanoacrylate ablation (CAA) and radiofrequency ablation (RFA), showing that CAA with the company's VenaBlock venous closure system "seems to be the ideal treatment" for great saphenous...
Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts to combat climate change. The announcement comes amidst the 2021 United Nations Climate Change Conference...
Mercator MedSystems has announced enrolment of the first patient in the DEXTERITY (Dexamethasone therapy examining reduction of inflammation after thrombus removal to yield benefit in DVT) Phase 2 clinical trial. Mercator’s proprietary Bullfrog micro-infusion device is a delivery solution...
A research team led by Lim Chwee Teck from the National University of Singapore’s (NUS; Singapore) Department of Biomedical Engineering and Institute for Health Innovation & Technology (iHealthtech), in collaboration with clinical partners from Singapore General Hospital (Singapore), has...
Inari Medical has announced positive acute and long-term interim results from the first 500 pulmonary embolism (PE) patients enrolled in the FlowTriever outcomes registry (FLASH).
A press release reports that, at 48 hours post procedure, the major adverse event rate...
Envveno Medical, formerly Hancock Jaffe Laboratories, recently announced that the first VenoValve surgery in the company’s SAVVE US pivotal trial for the VenoValve has been successfully completed. The surgery was performed by Adriana Laser, associate professor of surgery at...
Venclose recently announced US Food and Drug Administration (FDA) 510(k) clearance for Venclose Maven, a novel radiofrequency (RF) ablation catheter for minimally invasive treatment of incompetent perforator veins.
“While our existing Venclose RF ablation system, including the proprietary Venclose catheter,...
Three-year results of the VIVO clinical study support the continued safety and effectiveness of the Zilver Vena venous stent (Cook Medical) in the treatment of symptomatic iliofemoral venous outflow obstruction, a press release from the VIVA Foundation summarises. Paul...
Morwan Bahi (Wellington Regional Hospital, Wellington, New Zealand) presented five-year results of a retrospective, observational, single-centre study detailing outcomes for all patients with symptomatic lower limb chronic venous insufficiency treated with saphenous vein closure with VenaSeal (Medtronic) cyanoacrylate ablation...
Nearly half of patients deemed preprocedurally to be suffering an acute case of deep vein thrombosis (DVT) turned out to have a “much more” chronic classification of the condition following intraoperative imaging and thrombus inspection post-procedure, an interim analysis...
Koya Medical recently presented data from the company’s prospective, multicentre, randomised, crossover study comparing Dayspring, the company’s active compression treatment for lymphoedema, to a traditional pneumatic compression pump.
In the trial, study participants reported significantly greater adherence to Dayspring treatment...
Boston Scientific announced positive results for the EkoSonic endovascular system (EKOS system) during a late-breaking clinical trial presentation at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA). Data from the KNOCOUT PE registry—established to measure institutional adoption...
Thrombolex recently announced the results of the RESCUE trial’s prespecified interim analysis, of the first 62 evaluable patients, in a late-breaking clinical trials session at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA).
This pivotal trial is scheduled...
Preliminary clinical results from a first-in-human study assessing the Amplifi vein dilation system (Artio Medical) were presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October 2021, Las Vegas, USA). Data were presented by Surendra Shenoy—an associate professor of surgery at...
This article is sponsored by the European College of Phlebology.
It is a fact that the incidence of venous disease is rising; currently, 25% of Europe’s population is affected, and this figure will climb to 35% by 2050. Due to...
Koya Medical has received US Food and Drug Administration (FDA) 510(k) clearance for its Dayspring Lite treatment for lymphoedema and venous disease. Unlike traditional compression pumps that require patients to be tethered to the wall during use, the Dayspring...
In a comparison of endovascular versus hybrid treatment of chronic venous obstructions (CVOs) involving the confluence of the common femoral vein, researchers have found that both strategies provide similar patency rates. Writing online in the Journal of Vascular Surgery:...
Inari Medical has announced that the company has appointed Victor F Tapson as vice president of Medical Affairs.
Tapson has devoted his medical career to patient care, research, and teaching in pulmonary hypertension and pulmonary embolism, a press release reads....
A single-centre, prospective, randomised trial suggests that endovenous laser ablation (EVLA) using a 1470nm laser with a bare fibre (BF) provided outcomes in the short term similar to those using a radial fibre (RF).
Endothermal ablation has revolutionised the treatment...
Theraclion has announced US Food and Drug Administration (FDA) approval for the first trial with Sonovein in the USA. After this clinical trial, a full pivotal study will be conducted for FDA review for market authorisation.
The study will be...
LSO Medical has announced CE mark approval of its newest generation endovenous laser therapy (EVLT) SnakeBack assisted system, the Lumeseal laser platform. Designed to enhance ease-of-use and to provide greater precision and control throughout the procedure, Lumeseal is announced...
Today, Boston Scientific announced an agreement to acquire Devoro Medical, developer of the Wolf thrombectomy platform. The non-console and lytic-free Wolf technology targets and captures blood clots using finger-like prongs that retrieve and remove thrombi in the arterial and...
Thrombolex has announced that it will be attending The VEINS (Venous Endovascular INterventional Strategies) conference (Booth T8) and VIVA (Vascular InterVentional Advances) Physicians conference (Booth #502) in Las Vegas, USA from 3–7 October. There will be live demonstrations and...
The progress of two “promising” new devices in the venous valve replacement space were outlined during a special session at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) co-hosted...
“Among patients undergoing vascular surgery, thromboprophylaxis with anticoagulants showed a trend towards reduced incidence of VTE when compared to placebo,” Tarek Haykal (Duke University Medical Center, Durham, USA) and colleagues write in the Journal of Vascular Surgery: Venous...
Following an online-only conference in 2020, this year's iteration of the European Society for Vascular Surgery (ESVS) Annual Meeting will take a hybrid format, with sessions held in Rotterdam, The Netherlands and online from 28–29 September. In this letter,...
Advanced Oxygen Therapy Inc (AOTI) has announced that its multimodality Topical Wound Oxygen (TWO2) therapy was recently highlighted at multiple leading international clinical conferences across the USA and UK.
At this year's Malvern Diabetic Foot Conference (7–9 July, Malvern, UK, the growing...
New research published in Anaesthesia (a journal of the Association of Anaesthetists) shows that venous thromboembolisms (VTEs) are 50% more likely to occur in patients with current COVID-19 infection and almost twice as likely in those with recent infection. The...
The American College of Chest Physicians (CHEST) recently released new clinical guidelines for venous thromboembolism (VTE) management, “Antithrombotic therapy for VTE disease: Second update of the CHEST guideline and expert panel” that provides 29 recommendations on 17 Patients, Interventions, Comparators,...
Hancock Jaffe Laboratories has announced that promising two-year post-VenoValve implantation data are being presented today at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) by Jorge Ulloa (Fundacion Santa...
A new study suggests that the degree of intravascular ultrasound (IVUS)-determined iliofemoral venous stenosis does not appear to affect the initial clinical presentation, clinical-etiologic-anatomic-pathophysiological (CEAP) clinical class, supine foot venous pressure, clinical improvement, quality of life (QoL) improvement, stent...
Koya Medical recently announced that its wearable, active compression therapy system for lymphoedema—Dayspring—has been issued new billing codes by the Center of Medicare & Medicaid Services (CMS) in accordance with the Healthcare Common Procedure Coding System (HCPCS). According to...
Boston Scientific has commenced enrolment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz (Mainz, Germany) comparing use of...
Artio Medical announced today it has completed enrolment in its first-in-human study evaluating the Amplifi vein dilation system. In the study, five patients were treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción, Paraguay.
"I am very...
Hancock Jaffe Laboratories today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation status to the VenoValve, the company’s lead product, which is currently set to begin its US pivotal trial.
The VenoValve is a...
A large, single-centre retrospective study has revealed the risk of acute kidney injury (AKI) following pharmacomechanical thrombolysis (PMT) for lower extremity deep vein thrombosis (DVT) is as high as 22%.
PMT is an established treatment for selected patients with...
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In this case report for Venous News, experts outline the importance of recognising chronic venous obstruction as a crucial contributor to non-healing wounds in patients firstly...
Royal Philips today announced the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for a laser-assisted inferior vena cava (IVC) filter removal device. The proposed device is intended for ablating tissue to remove an IVC filter...
This advertorial, sponsored by BD, is only available in selected countries and geographies.
A downloadable version of this advertorial can be found here.
In this case report for Venous News, experts outline the importance of recognising chronic venous obstruction as...
Rachael Morris (London, UK) talks to Venous News about VEINES QoL/Sym—a venous disease-specific quality of life (QoL) questionnaire for patients with chronic venous insufficiency—as well as the findings of a study which sought to evaluate changes in venous-specific QoL...
Transluminal injection of foam sclerotherapy (TLFS) combined with endovenous laser ablation (EVLA) is a safe and feasible procedure that improves venous clinical severity score (VCSS) and reduces additional second-stage interventions compared to ultrasound-guided foam sclerotherapy (UGFS) combined with EVLA....
Based on findings presented at the 21st European Venous Forum (EVF) Annual Meeting (24–26 June, online), Imre Bihari (A+B Clinic, Budapest, Hungary) speaks to Venous News about the benefits of laser crossectomy.
What is the laser crossectomy technique used for...
Viz.ai has partnered with Avicenna.AI to enable intelligent care coordination and improve patient triage of patients suffering from pulmonary embolism (PE) and aortic disease.
Avicenna.AI’s US Food and Drug Administration (FDA)-approved algorithms for PE and type A and type B aortic...
Fist Assist Devices has announced a two-year affiliation with Airos Medical to commercialise and launch sales of the Fist Assist FA-1 device in the USA. The Fist Assist FA-1 is a wearable, patent-protected, intermittent compression device that recently received...
Surmodics recently announced that it has acquired privately-held Vetex Medical Limited. The Galway, Ireland-based medical device developer and manufacturer has focused exclusively on venous clot removal solutions. The transaction expands Surmodics’ thrombectomy portfolio with a second US Food and...
Despite a high rate of initial anticoagulation, patients with isolated superficial vein thrombosis (SVT) are at risk of thromboembolic complications—including recurrent or extended SVT and recurrent venous thromboembolism (VTE)—at three-month follow-up. This is according to the INSIGHTS-SVT (Investigating significant...
Venous disease-specific quality of life (QoL), as measured by the VEINES (Venous insufficiency epidemiological and economic study)-QoL/Sym, improves significantly after iliac vein stenting for chronic venous obstruction. This is according to the 2021 European Venous Forum (EVF) Prize-winning paper...
The US Food and Drug Administration (FDA) has enhanced the indications for use of the Bashir endovascular catheter (Thrombolex) and the Bashir Plus endovascular catheters (Bashir+10, Bashir+20, Bashir+30, Bashir+40; Thrombolex). These catheters are intended for the controlled and selective...
The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban) in paediatric patients.
The NDA seeks two...
Fist Assist Devices has received US Food and Drug Administration (FDA) 510(k) clearance for use of the Fist Assist FA-1 device in the USA as an arm massage and increased vein circulation device, and has commenced marketing the Fist...
Venous stenting can have myriad benefits for carefully selected patients with deep and pelvic venous disease. However, as venous stenting has quickly gained popularity, concerns have arisen about the appropriateness of its use and the potential complications that may occur.
Rick...
Among patients with a Caprini score of ≥11 who received standard prophylaxis for venous thromboembolism (VTE), adjunctive intermittent pneumatic compression (IPC) resulted in a significantly lower incidence of asymptomatic venous thrombosis.
This is according to the findings of the...
A study by Mayo Clinic researchers provides some clarity on the use of direct oral anticoagulants (DOACs), such as apixaban and rivaroxaban, to treat acute venous thromboembolism (VTE) in patients with gastrointestinal cancers. The findings were published 2 June...
Inari Medical today announced "strongly positive" interim results from the first 250 deep vein thrombosis (DVT) patients enrolled in the CLOUT (ClotTriever outcomes) registry. These latest data showed that the ClotTriever system removed 100% of the blood clots in...
A study suggests avoiding propofol for intraprocedural sedation during catheter-directed interventions (CDIs) for intermediate-risk pulmonary embolism (PE) because it can have detrimental effects. Propofol is the most commonly used parenteral anaesthetic agent in the USA, extensively used for minor...
Medical imaging artificial intelligence (AI) specialist Avicenna.AI recently announced that it has received certification in the USA and European Union (EU) for CINA CHEST, its new AI solution that leverages deep learning algorithms for emergency triage of deadly vascular...
Monroe Carell Jr Children's Hospital at Vanderbilt (Nashville, USA) has launched a study to determine the impact of a predictive model for identifying paediatric patients at risk for developing venous thromboembolism (VTE).
The study uses advanced predictive analytics to inform...
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphoedema and venous diseases that impact lymphatic flow in the lower extremities....
The European Union (EU) Medical Devices Regulation (MDR) takes effect from today (26 May 2021).
The Regulation revises quality and safety standards and the range of regulated devices and was first initiated in May 2017, with an initial three-year...
Boston Scientific and BD have both initiated recalls of venous stents. According to a US Food and Drug Administration (FDA) medical device recall notice posted 21 May, Boston Scientific has recalled its Vici venous stent system (Vici SDS) and...
LimFlow SA recently announced the publication of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep vein arterialisation (pDVA) system in the Journal of Vascular Surgery.
Results showed sustained positive outcomes...
Manjit Gohel (Cambridge, UK) and Stephen Black (London, UK) write that several recent advances in the management of venous thromboembolism (VTE) have provided clarity and consensus on this important topic. However, they stress that areas of controversy remain.
VTE has...
At VENOUS2021 (17–20 March, virtual), the annual meeting of the American Venous Forum, Geno Merli (Thomas Jefferson University Hospital, Philadelphia, USA) gave a keynote lecture on venous thromboembolism (VTE) in COVID-19 patients, detailing an “acute and extended” risk in...
The publication of positive new data and a need to minimise hospital visits during the COVID-19 pandemic has seen a general trend towards using more direct oral anticoagulants (DOACs), write Ankur Thapar, a consultant vascular surgeon, and Premalatha Sharavanan,...
While various treatment regimens for the “unique complication” of endothermal heat-induced thrombosis (EHIT) following endovenous ablation have been developed, Lowell S Kabnick tells Venous News, none have achieved universal acceptance. That is, he argues, until now. In this article,...
From the first research linking heparin to a reduction in fatal pulmonary embolism (PE), to the development and refinement of risk assessment tools to lower the risk of thrombosis, Joseph Caprini (University of Chicago Pritzker School of Medicine, Chicago,...
Sky Medical Technology has announced the inclusion of its flagship product, the Geko device, on a US Veterans Health Administration (VA) Federal Supply Schedule (FSS) contract awarded to its federal distribution partner, Marathon Medical.
The wearable, clinically proven Geko is...
As evolving treatment modalities offer the potential for improved outcomes in patients with deep venous disease, the importance of patient selection and the need for high-volume expert treatment centres to treat these patients were underscored by world-leading experts during...
An international panel of venous and lymphatic experts has called for a multidisciplinary approach to identify the causes of severely swollen lower limbs and to improve the treatment of this common condition, which has been poorly managed all over...
Hancock Jaffe Laboratories has revealed that the United States Patent and Trademark Office (USPTO) has issued the first patent covering the company's VenoValve. The patent is entitled 'Implantable Vein Frame' and is US patent number 10,959,841.
The company recently announced...
The results of a two-year study support the continued safety and effectiveness of the Zilver Vena Venous Stent (Cook Medical) in treating symptomatic iliofemoral venous outflow obstruction, according to findings presented at the 2021 meeting of the Society of...
Hancock Jaffe Laboratories recently announced that the US Food and Drug Administration (FDA) has approved the company's Investigational Device Exemption (IDE) application to begin the US pivotal trial for the VenoValve. The VenoValve is an implantable valve designed to...
A recent study on iliac vein stenting showed better short- and mid-term patency rates when intravascular ultrasound (IVUS) was utilised prior to stent deployment in addition to multiplanar venography compared to venography alone. The data were presented at VENOUS2021 (17–20...
According to a recent study, patients with cancer under immune checkpoint inhibitor therapy are at high risk of thromboembolism, especially venous thromboembolism (VTE). Furthermore, VTE occurrence was associated with increased mortality. Florian Moik (Comprehensive Cancer Center of MedUni...
Inari Medical has announced the enrolment of the first high-risk pulmonary embolism (PE) patient in the FLAME (FlowTriever for acute massive pulmonary embolism) study. One in 20 PE diagnoses is categorised as high risk and these are associated with...
Faced with a need to limit hospital visits and conserve personal protective equipment (PPE) in the wake of COVID-19, an 11-centre, hospital-based anticoagulation monitoring service (AMS) in Ohio, USA, needed to adapt fast. Addressing viewers of VENOUS2021 (17–20 March,...
A new review concludes that the implementation of clinical guidelines for the management of patients with deep vein thrombosis (DVT) varies among countries, from strict adherence to no adherence at all. “In this content,” suggest authors Carla Rognoni (SDA...
LimFlow announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Clinical Trial Notification (CTN) for the Japanese cohort of the ongoing PROMISE II pivotal trial of the LimFlow percutaneous deep vein arterialisation (pDVA) system.
PROMISE...
Long-term results of patients who underwent outpatient laser treatment for varicose veins at the great saphenous vein (GSV) or small saphenous vein (SSV) in 2008–2009 have been published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders.
The...
Vetex Medical has announced positive one-year outcomes from a European clinical study of the ReVene thrombectomy catheter. In patients with iliofemoral vein thrombus, the device was found to significantly improve symptoms and quality of life, while reducing leg swelling....
A new study has found that patients who require recanalisation of a completely occluded venous outflow tract before stenting have a high rate of early reocclusion. Writing in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, William A...
According to a recent study, longer segments of great saphenous vein (GSV) reflux appear to correlate with symptom severity. In addition, researchers noted a small to moderate correlation between length of GSV segment ablated and symptom improvement, which they...
Lowell Kabnick (Lake Worth, USA) talks to Venous News ahead of this year’s Charing Cross Symposium (CX), which is being held online 19–22 April. In 2021, the conference will focus on controversies within the vascular and endovascular space. Kabnick discusses...
Vetex Medical has announced US Food and Drug Administration (FDA) 510(k) clearance for the ReVene thrombectomy catheter.
ReVene uses dual-action technology designed to de-clot peripheral vessels, such as in deep vein thrombosis (DVT), through wall-to-wall contact in a single...
In a comparison of two clinical scales that assess quality of life (QoL) in post-thrombotic syndrome, Angela Lee (McGill University, Montreal, Canada) and colleagues conclude that, when a single scale is used for this purpose, the Villalta scale will...
In a recent meta-analysis, Yang Liu, Huan Lu (Henan Cancer Hospital, Zhengzhou, China), and colleagues found insufficient evidence to prove that inferior vena cava (IVC) filters can reduce pulmonary embolism (PE)-related mortality and overall mortality. However, they did find...
Results of a first-in-human study to assess the safety and feasibility of the Bashir endovascular catheter (Thrombolex) for the treatment of acute intermediate-risk pulmonary embolism (PE) have been published in Circulation: Cardiovascular Interventions.
Authors Akhilesh Sista (New York University...
The first patient has been enrolled in a postmarket clinical follow-up (PMCF) study of the BeYond venous self-expanding stent system (Bentley), a press release states. The stent was launched in a selection of venous centres across Europe in late 2020.
Michael...
Hancock Jaffe Laboratories recently announced that it has completed a public offering of its securities, generating approximately US$41.4 million of gross proceeds, prior to deducting underwriting discounts and commissions, and expenses. Proceeds from the offering will be used for...
Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) venous case volume and registry data entry was “sharply reduced” during the initial phase of the COVID-19 pandemic, a retrospective review has concluded. Findings were published online in the Journal...
Outcomes of the COMETA (Compression following endothermal ablation) study were published in the February edition of Annals of Surgery. The results suggest that wearing compression stockings after endothermal ablation is “advantageous in the first few days after treatment” and...
Bayer has received approval in the UK for the use of its oral Factor Xa inhibitor Xarelto (rivaroxaban) to treat venous thromboembolism (VTE) and to prevent VTE recurrence in children from birth to below 18 years after at least...
Michael Lichtenberg (Karolinen Hospital, Arnsberg, Germany) details three-year data from the Arnsberg venous registry on the VICI Venous Stent System (Boston Scientific).
This video forms part of a digital advertorial sponsored by Boston Scientific.
This advertorial is sponsored by Boston Scientific.
The VICI Venous Stent System (Boston Scientific) is associated with excellent primary patency rates, with concomitant symptomatic improvement in Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification, directly after stenting and in long-term follow-up out to 36 months....
The VICI Venous Stent System (Boston Scientific) is associated with excellent primary patency rates, with concomitant symptomatic improvement in Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification, directly after stenting and in long-term follow-up out to 36 months. This is the headline finding of...
“I consider intravascular ultrasound (IVUS) to be essential equipment in venous interventions,” Rick de Graaf (Clinic of Friedrichshafen, Friedrichshafen, Germany) told viewers of LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). De Graaf was speaking during a session...
Control Medical Technology recently announced that their US Food and Drug Administration (FDA)-cleared Control 11F mechanical thrombectomy system has been used to remove large blood clots from patients with deep vein thrombosis (DVT).
“The Control 11 French mechanical thrombectomy system...
A large, prospective, single-centre, randomised trial from Spain comparing two open surgical techniques with radiofrequency ablation (RFA) to treat saphenous incompetence found RFA comparable to both invasive approaches in terms of clinical recurrence and quality of life at two...
Inari Medical has announced strongly positive interim results of the first 64 chronic deep vein thrombosis (DVT) patients enrolled in the ClotTriever outcomes (CLOUT) registry. The subanalysis, which focused on patients with an estimated clot age over six weeks,...
Venous thromboembolism (VTE) in COVID-19 patients was a key topic on the agenda of The VEINS (Venous Endovascular INterventional Strategies) session at VIVA 2020 (Vascular InterVentional Advances; 14–15 November, virtual). Based on emerging data and guidelines, Yogen Kanthi (National...
The nature of venous thromboembolism (VTE) in COVID-19 patients is complex, and treatment strategies regarding drug type and dosing continue to evolve, writes Sanjum Sethi. In this context, Sethi concludes that a multidisciplinary approach to treatment, in the form...
Describing the Northwell CORE-19 registry as “the largest prospective registry of thromboembolic complications in hospitalised COVID-19 patients in the post-hospital discharge period,” lead investigator Alex Spyropoulos (Northwell Health and Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New...
The European Society for Vascular Surgery (ESVS) has produced a clinical practice guidelines document on the management of venous thrombosis—the first guidelines the society have produced on this topic. The document was published as an Editor’s Choice paper in...
Results from the EXTRACT-PE trial, which found that Penumbra’s Indigo aspiration system met its predefined safety and efficacy endpoints for the treatment of pulmonary embolism (PE), have been published in JACC: Cardiovascular Interventions.
Penumbra’s Indigo system is designed to remove...
A recent randomised controlled trial shows a potential role for higher density types of thermal water in lower limb volume control and quality of life improvement. Investigators Erica Menegatti (University of Ferrara, Ferrara, Italy) and colleagues write in an...
In this article for Venous News, Stephen A Black discusses innovation in the field of thrombolytic-free thrombectomy. He considers "exciting" new developments in mechanical-only approaches and concludes that, "We are making progress on our important objectives as vascular specialists...
The excimer laser sheath technique is safe and effective for removing embedded inferior vena cava (IVC) filters refractory to high-force retrieval, the investigators of a first-in-human escalation trial conclude in the Journal of the American Heart Association (JAHA). “This...
Mahmood Razavi (Orange, USA) speaks to Venous News about the recently initiated VIVID trial – a prospective, multicentre, single-arm study which has just begun enrolment and is designed to evaluate the safety and efficacy of the Vesper DUO Venous Stent System in the...
In a recent randomised controlled trial, an age-adjusted, weight-adjusted dabigatran dosing algorithm was found to be appropriate in children under 18 years old with venous thromboembolism (VTE). Writing in Lancet: Haematology, Jacqueline Halton (University of Ottawa, Ottawa, Canada) and...
In a recent study, factors related with venous thromboembolism (VTE) severity—including pulmonary embolism response team (PERT) referral from the intensive care unit (ICU) and right ventricular dysfunction—and elevated bleeding risk were associated with inferior vena cava (IVC) filter placement...
Aidoc and Imbio have announced a partnership intended to provide an end-to-end artificial intelligence (AI) solution for pulmonary embolism (PE), with the goal of ultimately improving efficiency and quality of PE detection and treatment.
"Achieving the value of AI in clinical...
Vesper Medical recently announced initiation of its US Food and Drug Administration (FDA) investigational device exemption (IDE) study—VIVID (Venous stent for the iliofemoral vein investigational clinical trial using the Vesper Duo venous stent system).
The VIVID trial is a prospective, multicentre, single-arm...
In a study of interface pressure changes under compression bandages, Junjie Ning, Fedor Lurie (both Jobst Vascular Institute, Toledo, USA), and colleagues found that while pressure decreased over time under all studied bandages, the temporal pattern of pressure change...
Cook Medical has announced that their Zilver Vena venous self-expanding stent is now commercially available to physicians in the USA.
Zilver Vena is a self-expanding stent designed to meet the needs of patients suffering from symptomatic iliofemoral venous outflow obstruction....
Penumbra today announced US Food and Drug Administration (FDA) 510(k) clearance for expanded indication of the latest iteration of the Indigo aspiration system, Lightning 12.
As part of the Indigo aspiration system, Lightning 12 (Indigo system CAT 12 aspiration catheter...
Amy Ferris (Geriatric and General Medicine Cardiff, Cardiff, Wales, UK), Keith Harding (Welsh Wound Innovation Centre, Ynysmaerdy, Wales, UK), and colleagues have landed on a “suitable protocol” for measuring serum and wound fluid iron levels in the context of...
Inari Medical has announced follow-up results of the first 230 patients enrolled in its FLASH study. FLASH is a real-world registry to study the FlowTriever system in intermediate- and high-risk pulmonary embolism (PE) patients.
A press release reports that...
Anthony Comerota (Alexandria, USA), global principal investigator of the VIVO trial, discusses the highlights of the 12-month results of the VIVO clinical study that were presented at VIVA 2020.
While the safety and efficacy of the Zilver Vena stent, which...
Vascular Barcelona Devices (VB Devices) recently announced that its Varixio Pod Air product received CE mark approval as a Class 1s medical device. Varixio is a novel, patent-protected system that automates the preparation of foam for sclerotherapy of varicose...
In September 2020, a consensus document outlining the Venous and Lymphatic Triage and Acuity Scale (VELTAS) was co-published in Phlebology and the Journal of Vascular Surgery: Venous and Lymphatic Disorders. The document, authored by representatives of various international societies,...
LimFlow SA has announced the presentation of one-year data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep vein arterialisation system, showing sustained positive outcomes for both amputation-free survival and complete wound healing....
Results of the VIVO clinical study support the safety and effectiveness of Cook Medical's recently FDA-cleared Zilver Vena venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction, Anthony Comerota (Inova Fairfax Hospital, Alexandria, USA) revealed in a...
Catalin Toma (University of Pittsburgh, Pittsburgh, USA) recently presented interim results from the FLASH registry during a late-breaking session at TCT Connect (14–18 October, virtual), the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF).
FLASH (FlowTriever all-comer registry...
An off-label randomised controlled trial (RCT) has found that an investigational stocking, which has no compression in the foot or heel area, is significantly easier to put on and take off, with no inferiority in oedema prevention, compared with...
Results of the ATLANTIS (Aquatic therapy to lower adverse consequences of venous thrombosis and insufficiency) randomised controlled trial (RCT) show that the addition of aquatic activity to the treatment of patients with advanced chronic venous insufficiency is safe and...
Medtronic today announced it has received US Food and Drug Administration (FDA) approval for the Abre venous self-expanding stent system. This device is indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction.
The FDA...
The BASHIR™ Endovascular Catheter offers a safe and easy-to-use platform technology, creating immediate blood flow, accelerating thrombolysis, and dissolving large volumes of thrombus burden. This educational supplement, sponsored by Thrombolex, explores the use of various catheter-directed therapies, including their...
The BAS (British Association of Sclerotherapists) interactive Masterclass Series kicked off on 8 October with three experts from the world of vascular surgery sharing their knowledge of 2020 varicose vein treatments.
One of the UK’s most experienced vein experts, Bruce...
Cook Medical today announced that the Zilver Vena received US Food and Drug Administration (FDA) premarket approval (PMA) in the USA. The product is expected to be commercially available to physicians in the USA in Q4 2020.
Zilver Vena is...
In a systematic review of the worldwide published data on venous thromboembolism (VTE) in COVID-19 patients, Cihan Ay, Stephan Nopp, and Florian Moik (Medical University of Vienna, Vienna, Austria) provide an in-depth analysis on the risk of VTE in...
Patients with venous thromboembolism (VTE) carry a high risk of recurrence. Accordingly, a 16-year Danish prospective cohort study of nearly 74,000 patients with incident VTE concluded that the risk of recurrence is substantial. Furthermore, the scientists found that the recurrence...
Midterm results from a study of the largest population of patients with no-option chronic limb-threatening ischaemia (CLTI) treated with percutaneous deep vein arterialisation (pDVA) using the LimFlow device show that, in this complex group of patients, this treatment method...
The American Venous Forum (AVF) is to stage a four-part series of educational sessions aimed at residents, fellows, and early-career practitioners in vascular surgery, interventional radiology, and a host of other specialties.
The live, virtual course—taking place at 8 pm...
Royal Philips has announced the launch of the QuickClear mechanical thrombectomy system. The single-use system delivers an all-in-one aspiration pump and catheter to remove blood clots from the vessels of the peripheral arterial and venous systems and has received...
To deliver clinical and cost benefits, leg ulcer care pathways should be revised to include early assessment and treatment of superficial venous reflux, researchers behind a recent Journal of the American Medical Association (JAMA) Surgery study suggest.
The investigators set...
In a recent nationwide study of observational data from the USA, intracranial haemorrhage (ICH) was found to be rare among deep vein thrombosis (DVT) patients treated with catheter-directed thrombolysis (CDT). The study showed that the incidence of ICH has...
A recent systematic review and meta-analysis compared the outcomes of both concomitant and staged superficial varicose tributary (SVT) interventions as an adjunct to endovenous truncal ablation. While both treatments demonstrated safety and efficacy, improvements in early disease severity and...
The Society of Interventional Radiology (SIR) recently published new clinical practice guidelines that provide evidence-based recommendations on the use of inferior vena cava (IVC) filters to treat venous thromboembolism (VTE).
“These guidelines allow physicians treating patients at risk of a...
In a recent analysis of 150 patients with post-thrombotic syndrome included in the Swiss and Arnsberg venous stent registries, braided as compared with laser-cut nitinol stents for common femoral vein obstruction appeared to be associated with favourable primary patency...
A new analysis has found that the incidence of cerebral venous thrombosis (CVT) in the USA is higher than previously reported and has increased over time.
According to an American Academy of Neurology press release, the study found the...
Patients with acute pulmonary embolism (PE) can be selected for home management using the sPESI score or the Hestia criteria, according to results of the HOME-PE trial presented in a Hot Line session at the European Society of Cardiology...
The Venovo venous stent system from BD has been revealed as one of the 2020 50th Annual Prix Galien USA award nominees in the "Best Medical Technology" category. The Prix Galien award is among the global health innovation industry's...
A recently-published study concludes that three-dimensional (3D) computed tomography venogram (CTV) enables accurate diagnosis and treatment of patients presenting with symptomatic chronic iliofemoral venous obstruction (CIVO).
Writing in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, authors Arjun...
The American Heart Association (AHA) has announced that after nearly a decade of steady decline, the death rate for people with pulmonary embolism (PE) reversed course and began rising over the past decade. The study was recently published online...
Three-year results of a randomised controlled trial reveal that, while mechanochemical ablation (MOCA) is a “feasible treatment option” in an outpatient setting, its technical success rates are inferior compared to endovenous thermal ablation. The findings were recently published online...
Thrombolex has announced that it has enrolled the first patient in its pivotal RESCUE trial for the treatment of patients with acute submassive pulmonary embolism (PE) using the Bashir endovascular catheter, under an Investigational Device Exemption (IDE) from the US...
A recent meta-analysis found that direct oral anticoagulants (DOACs) appear to be a “reasonable alternative” to low molecular weight heparin (LMWH) for the treatment of venous thromboembolism (VTE) in cancer patients. The study appeared online on 25 July in...
A randomised controlled trial has found that clinical and patient-reported outcomes following radiofrequency ablation (RFA) of varicose veins with compression are no better than without compression. Madu Onwudike (Manchester University NHS Foundation Trust, Manchester, UK) and colleagues conducted the...
Venous News takes a look back at VIVA 2019 (Vascular InterVentional Advances; 4–7 November, Las Vegas, USA) where Stephen Black (London, UK) and Mitchell Silver (Columbus, USA) discuss the CLEAR-DVT study.
Silver touches on some of the “historic studies” of venous intervention such as ATTRACT and CaVenT and compares them to CLEAR-DVT, which he...
Bentley has announced receipt of the CE mark for its BeYond venous self-expanding stent system. The company will initially launch the stent to an exclusive circle of leading venous experts to gain first-hand experience with this novel device.
The first-in-man...
PolarityTE have announced positive results from a protocol-specified interim analysis of the first 50 patients enrolled in a multicentre randomised controlled trial evaluating treatment of diabetic foot ulcers with SkinTE plus standard of care (SOC) versus SOC alone.
SkinTE is...
The International Society on Thrombosis and Haemostasis (ISTH), on behalf of the international thrombosis community, have called on the World Health Organisation (WHO) to share learning and support a systematic approach for managing venous thromboembolism (VTE) in patients with...
In a study evaluating rivaroxaban (Xarelto; Bayer) versus warfarin for the treatment and prevention of recurrent venous thromboembolism (VTE) in patients with obesity, results favoured rivaroxaban at three, six, and 12 months.
First author Olivia S Costa (University of...
Daiichi Sankyo Europe GmbH has announced results from five analyses of 12-month data from ETNA-VTE (Edoxaban treatment in routine clinical practice in patients with venous thromboembolism), a non-interventional, post-authorisation safety study (PASS) evaluating edoxaban (known by the brand name...
The International Society on Thrombosis and Haemostasis (ISTH) and the American Heart Association (AHA) have released a joint scientific statement identifying the top five priorities for research on venous thromboembolism (VTE); the statement has been published in the ISTH journal Research...
Thrombolex has announced that it was awarded a US$3 million Small Business Innovation Research (SBIR) grant from the National Heart, Lung and Blood Institute (NHLBI) section of the National Institutes of Health (NIH) to fund their pivotal RESCUE trial...
A recent study on iliac vein stenting showed lower long-term patency rates for women when compared to their male counterparts. The data were presented during the Vascular and Endovascular Surgical Society (VESS) session of SVS ONLINE (20 June–2 July)....
Manj Gohel (Cambridge, UK) is joined by a host of venous experts including Beverley Hunt (London, UK), Stephen Black (London, UK) and Ian Franklin (London, UK) to look at the long-term impact of the COVID-19 crisis on the treatment...
A poll of an enthused audience of venous specialists during the CX 2020 LIVE Deep Venous Disease Consensus session found that 91% of them were in favour of using venous stents. Armando Mansilha (Porto, Portugal) chaired the session. Moderator Manj Gohel (Cambridge, UK) subsequently...
Kathleen Gibson (Bellevue, USA) put the five-year data from the VeClose study, which looked at the treatment of patients with venous reflux in the great saphenous vein (GSV) with either the VenaSeal closure system (Medtronic) or radiofrequency ablation (RFA) therapy,...
Six venous specialists, Manj Gohel (Cambridge, UK), Ian Franklin (London, UK) Alun Davies (London, UK), Sriram Narayanan (Singapore), Raghu Kolluri (Columbus, USA) and Stephen Black (London, UK) discuss the role of telehealth during the COVID-19 crisis and...
Medtronic has announced the first-ever results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre venous self-expanding stent system in subjects with iliofemoral venous outflow obstruction. The study met the primary safety and effectiveness...
In this issue:
Compression stockings might not be needed to prevent blood clots after surgery (p. 1)
CX 2020 LIVE brings superficial venous thrombosis to the forefront (p. 1)
Paul Gagne considers the future of intravascular ultrasound (IVSU) for...
For the first venous session of CX 2020 LIVE, 759 attendees from 79 different countries tuned in. Each audience member could submit their name, country, and a question or point to the speaker in real-time, enabling interaction, discussion, and...
Transit Scientific has received US Food and Drug Administration (FDA) clearance for the XO Score percutaneous transluminal angioplasty (PTA) scoring sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic and/or native arteriovenous haemodialysis fistula.
Angioplasty...
BD has announced the launch of the Halo One thin-walled guiding sheath, designed to perform as both a guiding sheath and an introducer sheath, for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices.
According to...
VisionQuest Biomedical and the University of New Mexico School of Medicine have been awarded a three-year US$3 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH),...
New research published in the New England Journal of Medicine shows that the respiratory virus SARS-CoV-2, which causes COVID-19, causes severe damage to blood vessels, leading to widespread thrombosis, a press release by the Angiogenesis Foundation reports.
The study was...
A recent systematic review and meta-analysis showed that, in patients with iliofemoral deep vein thrombosis (DVT), percutaneous mechanical thrombectomy was associated with a higher cumulative six-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone....
Manj Gohel (Cambridge, UK), who is also a member of the CX Venous Executive Board, welcomes you to CX 2020 LIVE, which will include some of the major highlights from the deep and superficial venous programmes.
A number of recently...
Venous thromboembolism (VTE) is the leading cause of preventable hospital death in the USA and worldwide. A new policy statement by the American Heart Association provides a focused review of VTE, risk scoring systems, preventive measures for the hospital...
LimFlow SA today announced publication of positive two-year data from the ALPS registry of the LimFlow percutaneous deep vein arterialisation (pDVA) system. Results were published online yesterday in the Journal of Endovascular Therapy and will also appear in the...
Sky Medical Technology highlights a publication on 5 May 2020 in the Journal of Thrombosis and Haemostasis showing the incidence of venous thromboembolism (VTE) in 198 hospitalised COVID-19 patients. The overall rate was 42% at 21 days including patients in...
This video is only available in selected geographies
Stephen Black (London, UK) talks to VEITHtv about how the dedicated venous open-cell nitinol Abre stent (Medtronic) compares with other venous nitinol stents available, noting that it is very easy to use,...
Writing for Venous News, Paul Gagne considers the future of intravascular ultrasound (IVUS) based therapies for venous leg ulcers (VLUs). He concludes that while studies of IVUS guided stenting to date "have moved the ball far down the field,"...
The Charing Cross (CX) Symposium, with its world-class faculty and unique focus on live audience participation, has announced the launch of a not-to-be missed and timely vascular and endovascular education virtual event: CX 2020 LIVE.
Mark your calendars for this...
Compression stockings might be unnecessary to prevent blood clots in most patients undergoing non-emergency (elective) surgery, finds a clinical trial published by The BMJ today.
The results of the Graduated compression stockings as adjuvant to pharmaco-thromboprophylaxis in elective surgical patients...
Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy platform to remove blood clots from peripheral vessels.
"This FDA clearance quadruples our product offering and...
Manj Gohel (Cambridge, UK), one of the editors-in-chief of Venous News, introduces a special COVID-19 video with leading thrombosis and haemostasis experts, including Beverley Hunt (London, UK), Ian Franklin (London, UK), Francis Matthey (London, UK) and Sriram Narayanan (Singapore),...
The venous space continues to evolve in the United States, and many physicians are learning how to navigate through the challenges of the venous anatomy from their international peers. As a well-respected expert, the Galway-based interventional radiologist Dr. Gerard...
Venous News talks with Gerard O'Sullivan, FSIR, FEBIR, University College Hospital, Galway, Ireland. This article is supported by BD Interventional.
Disclosures: Dr. Gerard O'Sullivan reports he is a consultant/speaker for BD Interventional, Aspirex, Boston Scientific Corporation, Cook Medical, Marvao Medical,...
Prism Schneider (Cumming School of Medicine, University of Calgary, Calgary, Canada) and others write in a commentary in the Canadian Medical Association Journal—because of an increase in domestic violence during the pandemic—healthcare providers should be aware of the signs...
There is an “urgent need” to improve specific venous thromboembolism (VTE) diagnostic strategies and investigate the efficacy and safety of thromboprophylaxis in ambulatory COVID-19 patients. This is the conclusion of a recent study into venous and arterial thromboembolic complications...
A 2020 update on the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system and reporting standards, authored by Fedor Lurie (Jobst Vascular Institute, Toledo, USA; University of Michigan, Ann Arbor, USA) and colleagues, has been published in the Journal Vascular Surgery: Venous and...
On 18 March, the Centers for Medicare & Medicaid Services (CMS) recommended “limiting non-essential care and expanding surge capacity into ambulatory surgical centres and other areas” to conserve resources and staff for managing COVID-19 patients. However, in a statement...
The COVID-19 subcommittee of the American Venous Forum (AVF) has issued a white paper on considerations in prophylaxis and treatment of venous thromboembolism (VTE) in COVID-19 patients.
Jeffrey Mendola, director of Mission Advancement at the AVF, emphasises the importance...
Joseph A Caprini considers venous thromboemolism (VTE), patient risk assessment, and therapeutic challenges in the wake of the COVID-19 pandemic, concluding that "accurate thrombosis risk assessment for all coronavirus patients is advised".
Emergence of the coronavirus worldwide represents a pandemic...
In a brief report in Annals of Internal Medicine, Seongman Bae (Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea) and colleagues report that neither surgical nor cotton masks appear to be an effective approach for preventing the dissemination of SARS-CoV-2 from...
Manj Gohel, Stephen Black and Alun Davies consider the impact of the COVID-19 pandemic on patients with venous disease. They conclude: "Once the acute crisis has passed, we must work hard as a community to avoid the population of...
Royal Philips has announced that the US government and Philips agreed to team up to increase the production of hospital ventilators in its manufacturing sites in the USA.
Philips plans to double the production by May 2020 and achieve...
The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May this year. The postponement, a press...
In a new statement published on 2 April 2020, all 45 societies represented by the US Council of Medical Specialty Societies (CMSS)—over 800,000 physicians—emphatically declare their belief that all frontline healthcare professionals must have access to personal protective equipment...
The American College of Surgeons (ACS) today leapt to the defense of healthcare workers who are heading to work in the face of increasing concerns over personal protective equipment (PPE) shortages as the COVID-19 pandemic cuts trails across the...
As a podium talk at the annual meeting of the American Venous Forum (VENOUS 2020; 3–6 March, Amelia Island, USA), it represented a bit of an outlier. It was, the presenter admitted, the only non-scientific talk on the programme....
Mechanochemical ablation (MOCA) is a superior option to endovenous laser ablation (EVLA) for the treatment of primary varicose veins, according to the findings of a randomised controlled trial which compared the two modalities. Published in the Journal of Vascular...
It has been found that oral apixaban is noninferior to subcutaneous dalteparin for the treatment of cancer-related venous thromboembolism (VTE), as revealed by Giancarlo Agnelli (University of Perugia, Perugia, Italy) at the American College of Cardiology/World Congress of Cardiology’s...
Results of PRONOMOS, a randomised, controlled, noninferiority trial, have shown rivaroxaban to be more effective than enoxaparin in the prevention of major venous thromboembolic events, during a period of immobilisation after non-major orthopaedic surgery of the lower limbs. The...
During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of...
A viewpoint in the Journal of the American Medical Association (JAMA) has offered potential solutions to modifying ongoing randomised clinical trials during the COVID-19 pandemic. It aims to “minimise disruption and preserve integrity”, while still ensuring participant health and safety.
Authors Mary...
Use of autologous skin cell suspension (ASCS) in addition to compression has been shown to accelerate healing in large venous leg ulcers (VLUs), according to the results of a multicentre randomised trial conducted in the UK. Writing in the...
The American College of Surgeons (ACS) has announced the release of new clinical guidance for surgeons to curtail recommendations for elective surgical procedures, with the aim of preserving necessary resources for the care of critically ill patients during the...
The 2020 Charing Cross (CX) Symposium that was due to take place next month in London, UK, has been cancelled due to COVID-19.
In full, the statement from the CX Symposium team, reads:
"The CX Symposium team has made the difficult...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its response to the COVID-19 public health emergency in its day-to-day operations with industry.
The letter from...
Incorporating evidence collected since 2004, the latest revision of the CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification system has underlined a number of key updates relating to descriptions of chronic venous disease patients. “There has been a lot of information that has come...
“We found deficiencies in current indications for intervention, which may explain some of the overutilisation we have been encountering,” explained Elna Masuda (Straub Medical Center, Hawaii Pacific Health, Honolulu, USA), during an overview of the new 2020 appropriate use...
The Lindsay Leg Club Foundation has launched a new fundraising campaign in partnership with the Aviva Community Fund, in a bid to raise money for a new Leg Club. There are currently 44 Leg Clubs operating throughout the UK,...
According to a network meta-analysis, the VenaSeal system (Medtronic) is “a promising therapeutic option for anatomic success at six months”. This study, published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, also highlighted the lower number of...
Results of a 12-month study conducted by a group of Commonwealth physicians have demonstrated that endovenous valve formation in the deep venous system is feasible. Presented in the International Session at the annual meeting of the American Venous Forum...
Symptoms of restless leg syndrome are 34.5% more prevalent in patients with superficial venous insufficiency, according to a retrospective study presented by Aaron Dezube (St Elizabeth Medical Center, Brighton, USA). Although restless leg syndrome was identified in those without...
Thrombolex has announced that results of its First-In-Human (FIH) trial confirm the early safety and feasibility of using the Bashir Endovascular Catheter for pharmacomechanical catheter-directed thrombolysis (CDT), in patients with acute pulmonary embolism (PE).
The data, presented at the...
“Venous leg ulcers (VLUs) secondary to deep venous stenosis represents a distinct class of patients who require a unique treatment paradigm,” stated Abhisekh Mohapatra (University of Pittsburgh Medical Center, Pittsburgh, USA), presenting results of a multicentre retrospective study of...
A retrospective review of patients presenting with bilateral obstructive iliofemoral venous lesions has shown that contralateral limb symptoms improve following stenting of the worse ipsilateral limb. In addition to this, the study found that only a small proportion of...
In a case-control study of patients with perceived contraindications to anticoagulation, who either received or did not receive inferior vena cava (IVC) filters, no difference was found in the incidence of symptomatic pulmonary embolism (PE) at 90 days.
Presented...
Access Vascular has announced that it has received clearance from the US Food and Drug Administration (FDA) for the second generation of its HydroPICC peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less...
MolecuLight has announced the release of a "significant upgrade" to its I :X digital wound measurement feature that enables clinicians to more accurately and quickly capture digital wound area measurement. According to a statement, clinicians can now reliably detect more...
ATTRACT compared outcomes following pharmacomechanical thrombolysis (PMT) versus standard medical therapy (SMT), and while no benefit with PMT was demonstrated for femoropopliteal deep vein thrombosis (DVT), subgroup analysis of iliofemoral DVT demonstrated a reduction in moderate-to-severe post thrombotic syndrome...
Use of the ClotTreiver system (Inari Medical) for the treatment of lower extremity deep vein thrombosis (DVT) has demonstrated safety and efficacy, especially in “removing large volumes of lower extremity acute thrombus in a single session”. A retrospective review...
Investigators in The Netherlands, France and Belgium have developed a risk assessment model for venous thromboembolism (VTE). Published by The Lancet in EClinicalMedicine, the TRiP(cast) score (thrombosis risk prediction following cast immobilisation) is described as “a helpful tool in...