SurModics Announces First Patient Enrolled in IDE Study of SurVeil™ Drug-Coated Balloon

EDEN PRAIRIE, Minn.,  SurModics, Inc., a leading provider of medical devices and in vitro diagnostic technologies, today announced enrollment of the first patient in an early feasibility study of its proprietary SurVeil™ drug-coated balloon (DCB). This study is part of the company’s strategy to transform its medical device business from a provider of device coatings, to offering differentiated whole-product solutions to leading medical device customers.

SurModics received investigational device exemption (IDE) approval for the study from the U.S. Food and Drug Administration (FDA) in late 2015. The SurVeil DCB includes the company’s new, proprietary coating formulation for interventional vascular treatment of peripheral artery disease (PAD), and it is the first complete vascular medical device developed that will be clinically tested by SurModics.

“First and second generation DCBs demonstrated a biologic effect and improved patency in patients with PAD,” said Kenneth Rosenfield, M.D., section head, Vascular Medicine and Intervention at Massachusetts General Hospital, and chair of the SurModics Scientific Advisory Board. “The new generation of DCBs, which includes significant advances in technology, provides a great opportunity to further enhance patient outcomes.”

“We are pleased with the progress we made enrolling the first patient in this study of our proprietary SurVeil DCB,” said Gary Maharaj, president and CEO of SurModics. “We are proud to be on the path to offering highly differentiated whole-products solutions to our medical device customers.”

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 U.S., SurModics plans to gather meaningful data that could potentially accelerate future regulatory approvals.

Source: SurModics, Inc.