PQ Bypass Completes Enrollment in DETOUR2 Percutaneous Femoral-Popliteal Bypass Pivotal Study for Patients With Complex Peripheral Arterial Disease
FDA-designated Breakthrough Device now one step closer to PMA submission
PQ Bypass, an innovative medical device company pioneering advancements in the treatment of complex peripheral artery disease (PAD), announces enrollment of the final subject in the company’s flagship IDE, the DETOUR2 clinical trial. This important milestone occurs only a month after the Detour System entered the U.S. Food and Drug Administration’s Breakthrough Device Program.
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An image of PQ Bypass’ completed Detour Procedure (Photo: Business Wire).
DETOUR2 is led by National Co-Principal Investigators Sean Lyden, MD, Professor and Chairman of the Department of Vascular Surgery at the Cleveland Clinic, and Jihad Mustapha, MD, President, CEO and Director of Endovascular Interventions at Advanced Cardiac and Vascular Centers. Both National Co-PI’s receive compensation for their duties in this role.
“The speed with which we were able to enroll DETOUR2 in 2020 speaks