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Surmodics's next-gen drug-coated balloon gets IDE from FDA

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.

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