SurModics has announced enrolment of the first patient in an early feasibility study of its proprietary SurVeil drug-coated balloon (DCB). A press release states that 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 US 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, section head, Vascular Medicine and Intervention at Massachusetts General Hospital, Boston, USA, 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.”
Three clinical sites have been identified to participate in this early feasibility study for SurVeil. This study will include up to 15 patients and allow for the collection of data on product safety and usability before finalisation of the product design. By undertaking this first-in-human early feasibility study of the DCB in the USA, SurModics plans to gather meaningful data that could potentially accelerate future regulatory approvals.