CLINICAL OUTCOMES ARE PROVIDING PROMISING RESULTS

In addition to the current Phase 3 study, Vascular Therapies has completed three clinical studies evaluating the safety, feasibility, and performance of the Sirolimus‑eluting Collagen Implant in hemodialysis fistulas (arteriovenous fistulae and arteriovenous grafts) and above knee peripheral bypass graft surgery. Clinical outcomes using the Sirolimus‑eluting Collagen Implant have provided promising results.

The Current Phase 3 Study

The ACCESS Study is a Phase 3 randomized, single blind, multicenter study designed to evaluate the efficacy and safety of the Sirolimus eluting Collagen Implant in subjects undergoing surgery for creation of a new hemodialysis fistula. The study initiated in the third quarter of 2015 will be conducted in accordance with a Special Protocol Assessment (SPA) Agreement with the U.S. FDA.

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COMPLETED CLINICAL STUDIES

Caution: The Sirolimus-eluting Collagen Implant is an investigational product that is not available for sale in any country.