March 13, 2017, SUNNYVALE, Calif.--(BUSINESS WIRE)--PQ Bypass, today announced CE (Conformité Européenne) Mark approval for a trio of proprietary devices: TORUS™ Stent Graft System, PQ Snare, and PQ Crossing Device, which enables physicians to perform a fully percutaneous femoral-popliteal bypass in patients with TransAtlantic InterSociety (TASC) II C and D lesions in the superficial femoral artery due to peripheral artery disease (PAD).

More than 200 million people worldwide are affected by PAD, which is a potentially life-threatening condition.1 In complex PAD, arteries in the leg become blocked by extremely long segments of plaque, restricting blood flow to the lower extremities. This can lead to pain, loss of mobility and amputation. Historically, extremely long blockages were treated by open bypass surgery, however experts now consider an endovascular-first approach. While standard endovascular approaches decrease procedure morbidity associated with surgery, they have not yet demonstrated the durability of open bypass surgery.2 The DETOUR procedure, pioneered by PQ Bypass, is designed to match or exceed the durable patency associated with open surgical bypass, but achieve those results with a minimally invasive endovascular procedure that allows rapid return to full function.

The TORUS™ Stent Graft System is an expanded polytetrafluoroethylene (ePTFE) covered self-expanding nitinol stent intended to improve blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic TASC II C and D lesions. The PQ Snare and PQ Crossing Devices are intended for the retrieval and manipulation of atraumatic foreign bodies in the distal peripheral vasculature and to support the placement and positioning of guidewires in the peripheral vasculature, respectively.
“There is a great unmet need for a durable percutaneous option for these patients with extremely long blockages in the legs due to PAD,” said Dr. Sean Lyden, chairman of the Robert and Suzanne Tomsich Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute. “While other percutaneous approaches have been attempted, long-term success and patency have been difficult to achieve, resulting in limited options for these patients.”

The CE Mark approval was based on data collected in DETOUR I, a prospective, multi-center, core-lab reviewed single-arm trial designed to evaluate the safety and efficacy of the PQ DETOUR procedure in patients with TASC II C and D total occlusions in the femoral-popliteal anatomy. The 6-month results from DETOUR I, which were presented in January at the Leipzig Interventional Course (LINC 2017), met both primary safety and effectiveness endpoints.

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