Data Presented From the Early Feasibility Study of Surmodics' SurVeil DCB

November 6, 2018—Surmodics, Inc. announced that data from the PREVEIL early feasibility study of the company’s SurVeil drug-coated balloon (DCB) were shared in a late-breaking clinical trial presentation at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.

PREVEIL is a prospective, multicenter, single-arm trial taking place in the United States that is designed 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. The company advised that the SurVeil device is not yet approved for sale in the United States.

According to Surmodics, 12-month data from the study show that acute success measures of safety were achieved in 100% of patients. Additionally, investigators reported 100% freedom from clinically driven target lesion revascularization and target vessel revascularization at 12 months. The study also showed continued significant improvement in Rutherford classification, resting ankle-brachial index, and walking impairment questionnaire (WIQ) including walking distance, walking speed, and stair-climbing scores.

As with the 6-month results, median paclitaxel plasma concentration peaked immediately postprocedure (Cmax 1.07 ng/mL) and was undetectable at 30 days. The study also achieved secondary technical, device, and procedure success criteria.

At VIVA, the data presented included 12-month results from 13 patients (Rutherford class 2–4) with an average lesion length of 56 mm, who were treated with the SurVeil DCB at three clinical sites. Clinical assessments for the study include primary patency and late lumen loss through 6 months, plasma paclitaxel levels, and changes in Rutherford classification, ankle-brachial index/toe-brachial index, 6-minute walk test, and WIQ 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.

Kenneth Rosenfield, MD, commented in Surmodics' announcement, “The ongoing positive results from this study demonstrate that the SurVeil DCB has the potential to be a next-generation DCB with improved efficacy of drug transfer. These 12-month data continue to support the functionality and safety of the device.”

Dr. Rosenfield is Section Head, Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts. He is United States Coprincipal Investigator of the pivotal TRANSCEND randomized trial, which received an FDA investigational device exemption in July 2017 and began enrollment in November 2017 to study the SurVeil DCB to treat peripheral artery disease in the upper leg.