Surmodics Receives IDE Approval to Initiate Pivotal Trial of SurVeil DCB
July 26, 2017—Surmodics, Inc. announced that it has received an investigational device exemption (IDE) from the US Food and Drug Administration to initiate the TRANSCEND pivotal clinical trial of the company's 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 In.Pact Admiral DCB (Medtronic). Surmodics expects to initiate enrollment in the trial in the fourth quarter of the 2017 calendar year.
TRANSCEND will be led by National Co-Principal Investigators Kenneth Rosenfield, MD, and Gary Ansel, MD. The European Principal Investigator is Marianne Brodmann, MD.
The objective of the TRANSCEND pivotal trial is to evaluate the safety and effectiveness of the Surveil DCB for treating patients with symptomatic PAD caused by stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support regulatory approvals and reimbursement in the United States and Europe.
The trial will enroll up to 446 patients at approximately 60 sites in the United States and 18 outside the United States. Study participants will be randomized to undergo treatment with either the SurVeil DCB or the 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 through 12 months after the index procedure. All randomized patients will be followed through 36 months after the index procedure.
Dr. Rosenfield is Section Head of Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts. Dr. Ansel is System Medical Chief of the Vascular Program at OhioHealth in Columbus, Ohio. Dr. Brodmann is Substitute Head of the Division of Angiology, Department of Internal Medicine, Medical University of Graz in Graz, Austria.
According to Surmodics, the design of the SurVeil DCB includes the company’s drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Preclinical 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 company noted that the SurVeil DCB early feasibility study that was conducted in the United States met its primary endpoint by demonstrating peak paclitaxel plasma concentrations after the index procedure. Consistent with preclinical 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 United States and is for investigational use only.
In the company’s press release, Dr. Ansel commented, “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. DCB therapy for patients with lower extremity PAD is growing rapidly, and while results have been encouraging, there is significant room for improvement.”
Dr. Rosenfield, who serves as Chair of the Surmodics Clinical Advisory Board, stated, ”Surmodics’ expertise and capabilities in surface technology are evident in the design and preclinical performance of the SurVeil DCB. We’re excited about Surmodics’ capability to improve on the performance of existing DCBs.”