Data From Early Feasibility PREVEIL Study Presented for Surmodics SurVeil DCB
September 13, 2017—Surmodics, Inc. announced that data from the PREVEIL early feasibility study of the company’s SurVeil drug-coated balloon (DCB) were reported by Gary Ansel, MD, in a late-breaking clinical trial presentation at the VIVA 17, Vascular Interventional Advances, conference held September 11–14 in Las Vegas, Nevada.
PREVEIL is a prospective, multicenter, single-arm trial conducted in the United States to assess the safety and feasibility of the SurVeil DCB in the treatment of patients with symptomatic peripheral artery disease caused by de novo lesions of the femoral and popliteal arteries.
Dr. Ansel presented 6-month results from 13 patients (Rutherford class 2–4) at three clinical sites who were treated with the SurVeil DCB (average lesion length, 56 mm).
Clinical assessments included primary patency and late lumen loss through 6 months and plasma paclitaxel levels, along with changes in Rutherford classification, resting ankle-brachial index/toe-brachial index, 6-minute walk test, and Walking Impairment Questionnaire at 1, 6, 12, 24, and 36 months. Key secondary safety endpoints included freedom from major vascular complications, evidence of paclitaxel toxicity, or thrombolysis in myocardial infarction.
According to Surmodics, data from the study show that acute success measures of safety were achieved in 100% of patients. Results also showed primary patency of 100% and mean late lumen loss of 0.27 ± 0.54 mm at 6 months. Significant improvement in Rutherford classification, ankle-brachial index/toe-brachial index, 6-minute walk test, and Walking Impairment Questionnaire were seen at 30 days and 6 months. Median paclitaxel plasma concentration peaked immediately after the procedure (Cmax 1.07 ng/mL) and was undetectable at 30 days. Secondary technical, device, and procedure success criteria were achieved.
In the company's announcement, Dr. Ansel commented, “We are encouraged by the early patient data using the Surmodics SurVeil DCB platform and are excited to continue clinical evaluation of the product in the United States pivotal trial.” Dr. Ansel serves as Principal Investigator in both the PREVEIL trial and the SurVeil DCB pivotal trial, TRANSCEND.
In July 2017, Surmodics received an investigational device exemption from the US Food and Drug Administration to initiate the randomized TRANSCEND pivotal clinical trial of the SurVeil DCB. TRANSCEND will evaluate the SurVeil DCB for treatment for peripheral artery disease in the upper leg compared to the In.Pact Admiral DCB (Medtronic). Surmodics expects to initiate enrollment in the TRANSCEND clinical trial in the fourth quarter of 2017.