SurModics (NSDQ:SRDX) said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker.
The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The 1st-in-human study is slated to enroll 15 patients to examine the safety & usability of the SurVeil device before the design is finalized, SurModics said.
“We are pleased with the progress we made enrolling the first patient in this study of our proprietary SurVeil DCB,” president & CEO Gary Maharaj said in prepared remarks. “We are proud to be on the path to offering highly differentiated whole-products solutions to our medical device customers.”
“First- and 2nd-generation DCBs demonstrated a biologic effect and improved patency in patients with PAD,” added Dr. Kenneth Rosenfield, of the Mass. General Hospital and advisory board chairman for SurModics. “The new generation of DCBs, which includes significant advances in technology, provides a great opportunity to further enhance patient outcomes.”
SurModics in January paid $7 million and put another $7 million in milestones on the table for catheter maker NorMedix. Late last year the company paid $32 million for balloon catheter maker Creagh Medical.