US-based medical device company PQ Bypass has secured CE mark approval for its DETOUR percutaneous bypass technologies TORUS stent graft system, PQ Snare and PQ Crossing device.
The approval allows physicians to perform a fully percutaneous femoral-popliteal bypass called DETOUR procedure, in patients with TransAtlantic InterSociety (TASC) II C and D lesions associated with peripheral artery disease (PAD), in the superficial femoral artery.
The TORUS stent graft system is an self-expanding nitinol stent covered with expanded polytetrafluoroethylene (ePTFE).
It is designed to increase blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic TASC II C and D lesions.
Intended for the retrieval and manipulation of atraumatic foreign bodies in the distal peripheral vasculature, the PQ Snare supports the placement while the PQ Crossing device supports the positioning of guidewires in the peripheral vasculature.
PQ Bypass president and chief executive officer Peter Wehrly said: “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.
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"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.”
The approval was based on the results from a prospective, multi-centre, core-lab reviewed single-arm DETOUR I trial that assessed 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 six month results from the trial were found to have met both primary safety and effectiveness endpoints.