PQ Bypass Initiates TORUS 2 Pivotal SFA Study

November 4, 2019—PQ Bypass, Inc. announced that the first patient has been enrolled in the TORUS 2 multicenter clinical trial of the company’s self-expanding Torus stent graft system, which is designed for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). On October 8, the company announced the FDA’s approval of this investigational device exemption (IDE) trial.

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 SFA and/or the proximal popliteal artery.

Vaqar Ali, MD, Vice President, and Catheterization Lab Director at First Coast Cardiovascular Institute in Jacksonville, Florida, enrolled and treated the trial's first patient. Dr. Ali commented in the company’s announcement, “Our patient had a challenging SFA lesion that was treated thanks to the radial strength and flexibility afforded by the robust design of the Torus stent graft. We are thrilled to be the first site to enroll in this important trial and to be part of bringing this technology forward as a potential option for our patients.”

According to PQ Bypass, the pivotal trial will evaluate the Torus intra-arterial stent graft for occlusive and restenotic femoropopliteal revascularization. The prospective, single-arm trial will enroll 188 patients at up to 40 sites. The study is led by national coprincipal investigators Peter Schneider, MD, and Ehrin Armstrong, MD.

In PQ Bypass' press release, Dr. Schneider stated, "There is an unmet need in our care of PAD patients for an updated, optimized, and specifically designed stent graft for SFA-popliteal use. I believe this technology could become an important part of our endovascular armamentarium." Dr. Schneider is Professor of Surgery, Division of Vascular and Endovascular Surgery at the University of California San Francisco in San Francisco, California.

Dr. Armstrong added, "This study is intended to further the growing body of evidence for the TORUS stent graft. I am pleased to be involved in such an important step forward in the percutaneous treatment of PAD.” Dr. Armstrong is Director of Interventional Cardiology at the Rocky Mountain Regional VA Hospital and Professor of Cardiology at the University of Colorado School of Medicine, in Aurora, Colorado.

In 2017, the Torus device received European CE Mark approval for use in the company’s Detour percutaneous femoropopliteal bypass procedure. This approval was supported by 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 United States and Europe.