Clinical-stage medical device company PQ Bypass Inc revealed on Monday that it has initiated its TORUS 2 multi-centre clinical trial with the enrollment of the first patient.

PQ Bypass stated it has carried out the inaugural enrolment less than a month after the study received unconditional approval from the FDA for the TORUS 2 original IDE. Vaqar Ali MD, FACC, FSCAI, vice president and Cath Lab Director at First Coast Cardiovascular Institute in Jacksonville, Fla, enrolled and treated the first patient in the trial.

TORUS 2 is a trial of the company's self-expanding TORUS stent graft system, a novel technology designed for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). The objective of the trial is to evaluate the safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the superficial femoral and/or proximal popliteal arteries.

Led by national co-principal investigators Peter Schneider MD, Professor of Surgery, Division of Vascular and Endovascular Surgery at University of California San Francisco, and Ehrin Armstrong MD, MSc, FSCAI, Director of Interventional Cardiology at the Rocky Mountain Regional VA Hospital and Professor of Cardiology at University of Colorado School of Medicine, the PQ Bypass pivOtal IDE intra-aRterial stent graft study for occlUsive and re-Stenotic fem-pop revascularization is a prospective, single-arm trial of 188 patients at up to 40 sites.

The TORUS Stent Graft System received CE Mark in 2017 for use in the DETOUR percutaneous femoropopliteal bypass procedure, based on the DETOUR 1 global study. The technology has also been evaluated in the TORUS 1 study in Europe and is currently under evaluation in the DETOUR 2 IDE for percutaneous femoropopliteal bypass in the US and Europe.