SurModics touts six-month data for SurVeil DCB
The prospective, single-arm trial was designed to assess the safety and feasibility of the SurVeil DCB in the treatment of patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries.
The six-month data included results from 13 patients who were treated with the SurVeil DCB. The average lesion length for the group was 56 millimeters.
The study’s clinical measures included primary patency and late lumen loss through six months, plasma paclitaxel levels, resting ankle brachial index/toe brachial index, six-minute walk test and a walking impairment questionnaire at 1, 6, 12, 24 and 36 months.
Key secondary safety endpoints, the team reported, were freedom from major vascular complications, evidence of paclitaxel toxicity or thombolysis in myocardial infarction.
Acute success measures of safety were observed in 100% of the subjects, according to the six-month data. The data also showed primary patency of 100% and mean late lumen loss of 0.27 (+/- 0.54) millimeters at six months.
Median paclitaxel plasma concentration peaked immediately following the procedure, the company said, and was undetectable after 30 days.
“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 U.S. pivotal trial,” principal investigator Dr. Gary Ansel said in prepared remarks.
“Our goal with the SurVeil DCB is to improve drug transfer and effect on the arterial wall with a lower drug dose and a reduction in the amount of drug reaching tissue outside the area of treatment,” president & CEO Gary Maharaj added. “We are very satisfied with the results of the EFS and believe they are consistent with our encouraging pre-clinical data.”