PQ Bypass said today it won CE Mark approval for 3 devices designed to treat patients with superficial femoral artery lesions due to peripheral artery disease.
The Sunnyvale, Calif.-based company said it won clearance for its Torus stent graft system, PQ Snare and PQ crossing device, all used in the company’s Detour procedure.
“With an increased focus on value-based and patient-centered medicine, surgical advancements that minimize trauma to patients, reduce length of hospital stay and recovery times are critical global needs. CE Mark is an important milestone for PQ Bypass and we look forward to continuing our clinical studies, including an upcoming IDE study, with an eye toward FDA approval. Data presented at LINC 2017 demonstrated that the Detour procedure has clear potential as a viable change in how extremely long SFA occlusive disease is treated in the future,” CEO Peter Wehrly said in a prepared statement.
The PQ Detour procedure is a fully-percutaneous femoral-popliteal bypass procedure which uses fluoroscopic guidance to deploy Torus stent grafts from the popliteal artery into the femoral vein, and from the femoral vein into the superficial femoral artery through 2 independent anastomoses.
PQ Bypass’ Torus stent graft is an expanded polytetrafluoroethylene-covered self-expanding nitinol stent designed to improve blood flow in patients with symptomatic peripheral artery disease in superficial femoral artery de novo and restenotic TASC II C and D lesions.
“There is a great unmet need for a durable percutaneous option for these patients with extremely long blockages in the legs due to PAD. While other percutaneous approaches have been attempted, long-term success and patency have been difficult to achieve, resulting in limited options for these patients,” Dr. Sean Lyden of Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute said in a prepared release.
The company said its CE Mark approval was based on data from the prospective, multi-center Detour I trial, which reported meeting primary safety and effectiveness endpoints at 6-months. Results from the trial were released in January.
“The PQ Detour procedure is a truly new and innovative approach to treating patients with extremely long SFA lesions. The initial safety and effectiveness of the Detour procedure, as shown in the Detour I trial, is very encouraging and the results clearly demonstrate the potential for this to become a key addition to the treatment armamentarium for patients with complex PAD,” Detour I study investigator Dr. Dainis Krievins of Riga, Latvia’s Institute of Research of Pauls Stradins Clinical University Hospital said in a press release.