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 addressing long lesions that are not well served by existing minimally-invasive approaches. We look forward to working with the Detour II Trial clinical sites on this important research,” Detour II trial co-principal investigator Dr. Jihad Mustapha of the Michigan State University College of Osteopathic Medicine said in a prepared release.
The prospective, single-arm, multi-center trial will engage with patients at up to 40 sites to analyze safety and effectiveness data of the Detour system as the company seeks FDA pre-market approval. The trial will also include a prospective economic study to collect data related to costs associated with treating PAD.
“Patients with life-limiting claudication or critical limb ischemia typically have lesions longer than 15 cm, and we know that lesion length is directly proportional to patency. Until now, endovascular methods of treating these long lesions have not been comparable to open bypass surgery. The Detour procedure is designed to treat patients with severely calcified or long-segment disease. It’s essentially a femoropopliteal bypass with polytetrafluoroethylene, but done percutaneously. The Detour I trial in Europe demonstrated safety and efficacy in patients with lesions as long as 44 centimeters in length, and we look forward to continuing to study this procedure with the commencement of Detour II,” Detour II trial co-principal investigator Dr. Sean Lyden of the Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute said in a prepared statement.
In September, PQ Bypass released subset analysis results from the Detour 1 clinical trial of its Detour system designed to treat long-segment blockages in the femoropopliteal artery, touting a 2% rate of major adverse events and no deaths or amputations at 30 days.