August 15, 2017 — Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) in July to initiate a pivotal clinical trial of the SurVeil drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to the Medtronic IN.PACT Admiral DCB.
The SurVeil DCB pivotal trial (TRANSCEND) will be among the first trials in the United States to compare a next-generation DCB with a commercially-available DCB. The objective is to evaluate the safety and effectiveness of the device for treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support regulatory approvals (U.S. and Europe) and reimbursement.
The clinical trial will enroll up to 446 subjects at approximately 60 sites in the U.S. and 18 outside the U.S. Study participants will be randomized to receive either treatment with SurVeil DCB or IN.PACT Admiral DCB. The primary efficacy endpoint of the trial is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization (TLR) through 12 months post-index procedure. All randomized subjects will be followed through 36 months post-index procedure. Surmodics expects to initiate enrollment in the TRANSCEND clinical trial in the fourth quarter of calendar 2017.
The trial will be led by national co-principal investigators Kenneth Rosenfield, M.D., section head, vascular medicine and intervention at Massachusetts General Hospital, and Gary Ansel, M.D., system medical chief of the Vascular Program at OhioHealth. Marianne Brodmann, M.D., substitute head of the Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria, is the European principal investigator.
“By providing a head-to-head comparison with today’s market-leading DCB, the TRANSCEND trial will answer clinically important questions about the relative performance of DCBs,” said Ansel. “DCB therapy for patients with lower extremity PAD is growing rapidly, and while results have been encouraging there is significant room for improvement.”
The SurVeil DCB includes a proprietary drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Pre-clinical data have shown a three to five times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug concentrations compared to control DCBs.
The SurVeil DCB early feasibility study (EFS), conducted in the U.S., met its primary endpoint by demonstrating peak paclitaxel plasma concentrations post-index procedure. Consistent with pre-clinical data, systemic levels were low and cleared rapidly. No safety issues attributed to the product have been reported.
The SurVeil DCB is not available for sale in the U.S. and is for investigational use only.
For more information: www.surmodics.com