PQ Bypass announced today 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 restenotic fem-pop revascularisation) 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 coprincipal investigators Peter Schneider (Division of Vascular and Endovascular Surgery, University of California San Francisco, San Francisco, USA) and Ehrin Armstrong (Director of Interventional Cardiology, Rocky Mountain Regional VA Hospital; University of Colorado School of Medicine, Aurora, USA), this prospective, single arm study will enrol 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 USA.”
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.
The TORUS stent graft is limited by federal law to investigational use only and is not available for sale in the USA. For more information, please visit www.pqbypass.com