Seroba’s portfolio company, PQ Bypass Inc, a medical device company bringing new advancements to the treatment of peripheral artery disease (PAD), has announced that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device Exemption (IDE) study titled TORUS 2. This approval will affect coverage across all Medicare administrative regions.
TORUS 2 (The PQ Bypass pivOtal IDE intra-aRterial stent graft study for occlUsive and re-Stenotic fem-pop revascularization) will 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 (Division of Vascular and Endovascular Surgery, University of California San Francisco, U.S.) and Ehrin Armstrong (Director of Interventional Cardiology, Rocky Mountain Regional VA Hospital; University of Colorado School of Medicine, Aurora, U.S.), this prospective, single arm study will enroll up to 188 patients at up to 40 sites.
“The TORUS Stent Graft System represents the first major stent graft advancement in more than a decade for patients with SFA lesions and is the vanguard for the next generation of medical devices,” says Heather Simonsen, General Manager of PQ Bypass. “Currently, patients and physicians have only one stent graft option, which gained approval for the SFA in 2005, on the market in the United States.”
Previously studied in the DETOUR 1 and TORUS 1 studies in Europe, and currently under investigation in the DETOUR 2 IDE trial, the TORUS stent graft was granted CE mark as a part of the DETOUR procedure in 2017.
PQ Bypass, Inc. is a Silicon Valley-based medical device company pioneering treatments for peripheral artery disease (PAD). The company’s physician-driven innovations include the TORUS Stent Graft, PQ Snare, and PQ Crossing Device. These technologies are currently being evaluated in two global, multicenter, IDE studies: DETOUR 2 and TORUS 2. DETOUR 2 is focused on SFA lesions >200 mm via a novel percutaneous femoropopliteal bypass procedure, and TORUS 2 is focused on SFA lesions <180mm in length. Crafted by world-renowned experts in the field of PAD, PQ Bypass devices are built upon nearly a decade of research and patented technological advancement. PQ Bypass is recognized by MedTech Outlook magazine as one of the Top 10 Cardiovascular Companies of 2019 and earned Frost and Sullivan’s European Technology Innovation Award for the DETOUR procedure in 2017.
The TORUS stent graft is limited by federal law to investigational use only and is not available for sale in the U.S. For more information, please visit www.pqbypass.com