SurModics shares were higher 3% on Wednesday after the company said the US Food and Drug Administration has granted an investigational device exemption so that SurModics can start a clinical trial of its SurVeil drug-coated balloon. The randomized trial will evaluate the SurVeil balloon for treatment for peripheral artery disease in the upper leg compared to the Medtronic’s (MDT) IN.PACT Admiral balloon.
The trial will enroll up to 446 subjects at approximately 60 sites in the U.S. and 18 outside the U.S. The primary efficacy endpoint is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization through 12 months post-index procedure. All randomized subjects will be followed through 36 months post-index procedure. Surmodics expects to initiate enrollment in Q4.