Surmodics has obtained an investigational device exemption from the FDA to conduct a pivotal clinical trial of its SurVeil drug-coated balloon. The 446-patient study, which has a primary endpoint of primary patency at 12 months, seeks to assess use of the next-generation device for treating peripheral artery disease in the upper leg, compared with Medtronic's IN.PACT Admiral DCB.
Surmodics's next-gen drug-coated balloon gets IDE from FDA
Sign up for AdvaMed SmartBrief
Medical technology news
Get the intelligence you need: news and information that is changing your industry today, hand-curated by our professional editors from thousands of sources and delivered straight to your inbox.