FDA News

Percutaneous femoropopliteal bypass system receives IDE approval

Sean P. Lyden

PQ Bypass Inc. announced in a press release that it has received conditional approval of its investigational device exemption from the FDA to begin the first-ever pivotal trial for percutaneous femoropopliteal bypass.

The DETOUR II clinical trial is designed to evaluate the safety and efficacy of the DETOUR system, which performs revascularization via modular stent graft bypass using the femoral vein as a conduit, in up to 292 patients with lower limb ischemia due to blockages larger than 15 cm in the superficial femoral artery due to peripheral artery disease.

“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,” Sean P. Lyden, MD, professor and chairman of the department of vascular surgery at the Sydell and Arnold Miller Family Heart and Vascular Institute at Cleveland Clinic, said in a press release. “Until now, endovascular methods of treating these long lesions have not been comparable to open bypass surgery.”

The prospective, single arm, global multicenter trial will be conducted at up to 40 sites and is designed to treat patients with severely calcified or long-segmented disease.

Jihad A. Mustapha

According to Lyden, the procedure is comparable to a femoropopliteal bypass with polytetrafluoroethylene, but performed percutaneously.

“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,” Jihad A. Mustapha, MD, clinical associate professor of medicine at Michigan State University College of Osteopathic Medicine, said in the release. “We look forward to working with the DETOUR II trial clinical sites on this important research.”

Disclosure: Lyden reports he receives honoraria from Endologix; consults for Biomet, Endologix, PQ Bypass and Spectranetics; receives research funding from Bard Peripheral Vascular, Biomet, Bolton Medical, Boston Scientific, Cook Medical, Cordis, Endologix, the NIH, Spectranetics and W.L. Gore and Associates. Mustapha reports that he consults for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Medtronic, Spectranetics and Terumo Medical.

 

Sean P. Lyden

PQ Bypass Inc. announced in a press release that it has received conditional approval of its investigational device exemption from the FDA to begin the first-ever pivotal trial for percutaneous femoropopliteal bypass.

The DETOUR II clinical trial is designed to evaluate the safety and efficacy of the DETOUR system, which performs revascularization via modular stent graft bypass using the femoral vein as a conduit, in up to 292 patients with lower limb ischemia due to blockages larger than 15 cm in the superficial femoral artery due to peripheral artery disease.

“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,” Sean P. Lyden, MD, professor and chairman of the department of vascular surgery at the Sydell and Arnold Miller Family Heart and Vascular Institute at Cleveland Clinic, said in a press release. “Until now, endovascular methods of treating these long lesions have not been comparable to open bypass surgery.”

The prospective, single arm, global multicenter trial will be conducted at up to 40 sites and is designed to treat patients with severely calcified or long-segmented disease.

Jihad A. Mustapha

According to Lyden, the procedure is comparable to a femoropopliteal bypass with polytetrafluoroethylene, but performed percutaneously.

“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,” Jihad A. Mustapha, MD, clinical associate professor of medicine at Michigan State University College of Osteopathic Medicine, said in the release. “We look forward to working with the DETOUR II trial clinical sites on this important research.”

Disclosure: Lyden reports he receives honoraria from Endologix; consults for Biomet, Endologix, PQ Bypass and Spectranetics; receives research funding from Bard Peripheral Vascular, Biomet, Bolton Medical, Boston Scientific, Cook Medical, Cordis, Endologix, the NIH, Spectranetics and W.L. Gore and Associates. Mustapha reports that he consults for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Medtronic, Spectranetics and Terumo Medical.