BD has announced that the US Food and Drug Administration (FDA) has granted premarket approval for the Venovo venous stent, the first stent indicated to treat iliofemoral venous occlusive disease.
The Venovo venous stent is a flexible nitinol stent specifically designed to reopen blocked iliac and femoral veins in order to maintain adequate blood flow. The stent is designed with a balance of radial strength, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths.
“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” says Michael Dake (University of Arizona, Tucson, USA), the principal investigator for the Venovo investigational device exemption (IDE) trial. “Most importantly,” says Dake, “it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing.”
Iliofemoral venous occlusive disease occurs when there is impaired blood flow in the iliofemoral vein caused by acute or chronic deep-vein thrombosis, post-thrombotic syndrome, iliofemoral vein compression including May-Thurner Syndrome or a combination of these diseases. Symptoms include swelling of the legs, pain when standing, skin discoloration and ulcers.
One-year results from the prospective, multicentre single-arm VERNACULAR trial involving 170 subjects demonstrated the safety and effectiveness of the venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction. The data were presented by Dake at the 2018 Vascular InterVentional Advances meeting (VIVA; 5–8 November, Las Vegas, USA).
The clinical findings showed a weighted primary patency rate of 88.3%, with a 96.9% patency rate in non-thrombotic lesions and an 81.3%t patency rate in post-thrombotic lesions at 12 months, exceeding the performance goal of 74%. In addition, patients treated with the venous stent reported a statistically significant reduction in pain symptoms and improvement in quality of life (assessed by CIVIQ-20) at 12 months from baseline. The stent was also deployed successfully to the target lesion and showed adequate coverage in all cases, and there were no fractures seen at 12 months.
“The FDA premarket approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an underrecognised condition,” said Steve Williamson, worldwide president of Peripheral Intervention at BD. “We designed the Venovo venous stent in collaboration with clinicians to enable them to treat both post-thrombotic and non-thrombotic lesions. Clinicians will now have access to the broadest range of stent sizes in the USA for these difficult-to-treat lesions.”
The Venovo venous stent is commercially available in the USA, Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan.