December 19, 2019
CMS Approves Coverage for PQ Bypass TORUS 2 IDE Trial
December 19, 2019—PQ Bypass Inc. announced it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the TORUS 2 investigational device exemption (IDE) study. This approval will affect coverage across all Medicare administrative regions.
According to PQ Bypass, TORUS 2 is a pivotal multicenter clinical trial evaluating 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 the IDE trial. On November 4, the company announced that the first patient was enrolled in the trial.
TORUS 2 will evaluate the safety and effectiveness of the Torus stent graft system in the treatment of obstructive atherosclerotic lesions of the SFA and/or proximal popliteal artery. The prospective, single-arm study will enroll up to 188 patients at up to 40 sites and is focused on SFA lesions < 180 mm in length. The trial’s national coprincipal investigators are Peter Schneider, MD, and Ehrin Armstrong, MD.
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. DETOUR 2 is focused on SFA lesions > 200 mm via this novel percutaneous femoropopliteal bypass procedure.
The Torus stent graft is limited by federal law to investigational use only and is not available for sale in the United States, advised the company.