Surmodics' SurVeil study says data met primary endpoint and secondary endpoints
Surmodics announced that data from the PREVEIL early feasibility study of the company's SurVeil drug-coated balloon was shared in a late-breaking clinical trial presentation at the Vascular Interventional Advances 2018 conference in Las Vegas. PREVEIL is a prospective, U.S., multi-center, single-arm trial designed to assess the safety and feasibility of the SurVeil DCB in the treatment of subjects with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. Twelve-month data from the study show that acute success measures of safety were achieved in 100 percent of subjects. No subjects required re-intervention of either the target lesion or the target vessel at 12 months. The results also demonstrate continued significant improvement in Rutherford classification, resting ankle brachial index, and walking impairment questionnaire including walking distance, walking speed and stair-climbing scores at 12 months. As was presented with the six-month results, median paclitaxel plasma concentration peaked immediately post-procedure and was undetectable at 30 days. Secondary technical, device, and procedure success criteria were achieved. The SurVeil DCB is not yet approved for sale in the United States.