Enrollment Begins in IDE Study of SurModics' SurVeil Drug-Coated Balloon

April 13, 2016—SurModics, Inc. announced enrollment of the first patient in an early feasibility study of the company’s SurVeil drug-coated balloon (DCB), which features SurModics’ new coating formulation for interventional vascular treatment of peripheral artery disease (PAD). SurModics received investigational device exemption (IDE) approval for the PREVEIL study from the US Food and Drug Administration in late 2015. 

According to SurModics, this study is part of a strategy to transform their medical device business from being a provider of device coatings to offering differentiated whole-product solutions to leading medical device customers. The SurVeil DCB is the first complete vascular device developed and clinically tested by SurModics.

Three clinical sites have been identified to participate in this early feasibility study for the SurVeil DCB. This study will include up to 15 patients and allow for the collection of data on product safety and usability before finalization of the product design. By undertaking this first-in-human early feasibility study of the SurVeil DCB in the United States, SurModics plans to gather meaningful data that could potentially accelerate future regulatory approvals.

Kenneth Rosenfield, MD, who serves as Chair of the SurModics Scientific Advisory Board, commented in the company’s announcement, “First- and second-generation DCBs demonstrated a biologic effect and improved patency in patients with PAD. The new generation of DCBs, which includes significant advances in technology, provides a great opportunity to further enhance patient outcomes.” Dr. Rosenfield is Section Head of Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts.

The SurVeil DCB’s new features include the company’s drug-excipient formulation for the balloon coating, a new manufacturing process for the coating applications, and SurModics’ Serene hydrophilic coating on the catheter shaft. The SurVeil DCB is not available for sale in the United States and is for investigational use only, advised the company.