PQ Bypass Receives FDA “Breakthrough Device Designation” for the World’s First Fully Percutaneous Femoral-Popliteal Bypass Device
PQ Bypass advises physician access to this device can now be expedited as a result of this designation by the FDA Breakthrough Device Program, which is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
PQ Bypass Announces First Patient Treated in Landmark DETOUR II Trial Evaluating New Treatment Approach for Clogged Leg Arteries
2/22/18: PQ Bypass, a clinical-stage medical technology company that has developed the DETOUR procedure, a novel treatment for long (>15 cm) superficial femoral artery (SFA) blockages, announced enrollment of the first patients in the pivotal DETOUR II Trial in the United States. The trial is a prospective, single-arm clinical trial designed to evaluate the DETOUR™ System for percutaneous femoropopliteal bypass.