March 12, 2017
CE Mark Granted for PQ Bypass' Detour Percutaneous Bypass Technologies
March 13, 2017—PQ Bypass, Inc. announced CE Mark approval for three devices designed to enable percutaneous femoral-popliteal bypass: the Torus stent graft system, the PQ snare, and the PQ crossing device.
The Torus stent graft system is an expanded polytetrafluoroethylene-covered self-expanding nitinol stent for use in long, symptomatic TransAtlantic InterSociety (TASC) II C and D de novo and restenotic lesions in the superficial femoral artery (SFA) caused by peripheral artery disease (PAD). The PQ snare is intended for the retrieval and manipulation of atraumatic foreign bodies in the distal peripheral vasculature. And, the PQ crossing device supports the placement and positioning of guidewires in the peripheral vasculature.
The company stated that the CE Mark approval was based on data collected in DETOUR I. The prospective, multicenter, core-lab–reviewed single-arm DETOUR I study was designed to evaluate the safety and efficacy of the PQ Detour procedure in patients with long-segment TASC II C and D total occlusions in the femoral-popliteal anatomy. The 6-month results from DETOUR I were presented in January at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany. The study met both primary safety and effectiveness endpoints.
According to the company, the PQ Bypass Detour procedure is designed to match or exceed the durable patency associated with open surgical bypass, but to achieve those results with a minimally invasive endovascular procedure that allows rapid return to full function. The fully percutaneous femoral-popliteal bypass Detour procedure uses fluoroscopic guidance to deploy a series of Torus stent grafts from the popliteal artery into the femoral vein, and from the femoral vein into the SFA in a continuous, overlapping fashion through two independent anastomoses. The final result is a large-lumen endograft bypass that delivers unobstructed, pulsatile flow from the SFA ostium to the popliteal artery, restoring blood flow to the lower extremities.
In the company's press release, Sean Lyden, MD, commented, “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. Lyden is Chairman of the Robert and Suzanne Tomsich Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute in Cleveland, Ohio.
Dainis Krievins, MD, a DETOUR I investigator, added, “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 study, is very encouraging, and the study results clearly demonstrate the potential for this to become a key addition to the treatment armamentarium for patients with complex PAD.” Dr. Krievins is Professor of Vascular Surgery at University of Latvia, and Director of the Institute of Research of Pauls Stradins Clinical University Hospital in Riga, Latvia.