TRANSCEND Pivotal Clinical Trial Commences for Surmodics' SurVeil DCB
November 2, 2017—Surmodics, Inc. announced enrollment of the first patient in TRANSCEND, the pivotal clinical trial for 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 In.Pact Admiral DCB (Medtronic), a commercially available DCB.
According to Surmodics, up to 446 patients will be enrolled and randomized 1:1 to either the SurVeil DCB or the In.Pact Admiral DCB at approximately 60 sites in the United States and 18 sites outside the United States.
TRANSCEND will evaluate the safety and effectiveness of the SurVeil DCB for treatment of patients with symptomatic PAD caused by stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support United States and Europe regulatory approval and reimbursement. The SurVeil DCB is not available for sale anywhere in the world and is for investigational use only.
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 60 months postindex procedure.
Kenneth Rosenfield, MD, Section Head, Vascular Medicine and Intervention at Massachusetts General Hospital, in Boston, Massachusetts, is Chair of the Surmodics Clinical Advisory Board. He serves as the United States Co-Principal Investigator for the TRANSCEND trial. The trial will also be led by national Co-Principal Investigator Gary Ansel, MD, and European Principal Investigator Marianne Brodmann, MD.
In the company's announcement, Dr. Rosenfield commented, “Based on the preclinical and early feasibility study results we have seen so far, I am excited about the potential of the SurVeil DCB as a third-generation DCB to improve the treatment of PAD. TRANSCEND will be a rigorous level 1 trial that will answer important questions about DCB technologies.”
The SurVeil DCB includes Surmodics' drug excipient formulation for the balloon coating and is manufactured using the company's 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 particles compared to control DCBs, noted the company.