Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries.
All of the study’s 13 subjects met the acute success measures of safety at 12 months, Surmodics reported, and no participants required re-intervention of either the target lesion or the target vessel.
The data also supported improvements in Rutherford classification, resting ankle brachial index and walking impairment after 12 months.
“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,” co-principal investigator Dr. Kenneth Rosenfield said in prepared remarks. “These 12-month data continue to support the functionality and safety of the device.”
“Our goal all along with the SurVeil DCB has been to advance the technology to improve drug transfer and distribution effect on the arterial wall offering the opportunity to use a lower drug dose,” president & CEO Gary Maharaj added. “We are pleased with the ongoing results from the EFS and look forward to the opportunity to continue to demonstrate the potential for this technology with outcomes from our pivotal Transcend clinical trial that is currently underway.”