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 the results were strongly positive. Just one death (0.4%) was reported at 30 days. By contrast, the national PERT Consortium Quality Database recently showed 30-day mortality rates of 25.9% and 6.1% for high- and intermediate-risk PE patients. In addition, the FLASH Registry showed a readmission rate of 6.7%, compared to the nearly 25% readmission rate shown in the PERT Database. Efficacy data showed normalisation or near normalisation in a battery of haemodynamic variables like pulmonary artery pressure, RV/LV ratio, and heart rate, as well as dyspnoea (shortness of breath) metrics.
FLASH is a 500-patient prospective, multicentre, single-arm registry evaluating real-world patient outcomes after treatment of PE with FlowTriever. Interim data were obtained across 19 US sites, and results were presented virtually by national principal investigator Catalin Toma (UPMC Heart & Vascular Institute, Pittsburgh, USA) at the American Heart Association (AHA) Scientific Sessions 2020 (13–17 November).
These data follow the presentation of equally compelling acute data from the same patient set delivered at the annual TCT meeting (14–18 October, virtual). The acute results showed, at 48 hours, no deaths, no cardiac injuries, no pulmonary injuries, no procedure-related clinical deteriorations, and no intracranial haemorrhages in this highly compromised PE patient population. The TCT data also showed clinically and statistically significant improvement in haemodynamic parameters while the patient was still on the table. Post-procedure median ICU stay was 0 days. The new FLASH data released at AHA extends the study follow-up period to 30 days and demonstrates the durability of these acute results with continued improvement in outcomes over time.
“FLASH has shown us that PE patients experience symptom relief and improved cardiac function immediately upon removal of significant clot burden. These outcomes continue to improve over time. In fact, for a high percentage of these patients, measurements for dyspnoea, right heart strain, pulmonary artery pressure, and heart rate actually normalised after FlowTriever thrombectomy. We believe this suggests that removal of large clot burden with the FlowTriever system not only has an important impact acutely, but might have an important positive effect on long term implications of PE, like CTED and CTEPH,” said Toma.
“With over 60% of patients in FLASH having no contraindication to lytics, the study data suggests that FlowTriever is emerging as a frontline therapy for intermediate and high-risk PE patients, regardless of patient eligibility for other treatment options. PE care pathways are evolving,” said Thomas Tu, chief medical officer of Inari Medical. “Venous thromboembolism (VTE) patients are central to everything that we do at Inari, and we remain committed to advancing the treatment of this disease through clinical research and the continued development of purpose-built devices.”