PQ Bypass wins IDE nod for Detour percutaneous femoropopliteal bypass study

PQ Bypass said today it won FDA investigational device exemption approval to launch a pivotal clinical trial of its Detour percutaneous femoropopliteal bypass system designed to treat patients with peripheral artery disease. The company’s Detour II clinical trial will look to enroll up to 292 patients with lower limb ischemia due to long blockages over 15 cm in the superficial femoral artery, the Sunnyvale, Calif.-based company said. “We worked closely with the FDA, leading physicians and healthcare administrators to design a trial that we expect to demonstrate the total value of this unique approach to treating severe PAD. Detour II is an exciting milestone in the journey toward establishing a potentially transformative future standard of care for these patients,” PQ Bypass board chair Richard Ferrari said in a press release. The Detour procedure is designed around the company’s Detour system which includes a Torus stent graft, Detour crossing device and Detour snare. The procedure creates a pathway originating in the SFA and traveling through the femoral vein to end in the popliteal artery, bypassing parts of the artery affected by disease. The Torus stent grafts are designed to be placed in a continuous line to re-direct blood around the blockage and restore blood flow to the lower leg and foot in patients, the company said. “The Detour System features a truly innovative, intuitive design and the trial will investigate its benefits in address...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Regulatory/Compliance Stent Grafts Vascular PQ Bypass Source Type: news