AP NEWS
Press release content from Business Wire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Business Wire
Press release content from Business Wire. The AP news staff was not involved in its creation.

CMS Approves Coverage for PQ Bypass TORUS 2 IDE Trial

December 19, 2019 GMT

MILPITAS, Calif.--(BUSINESS WIRE)--Dec 19, 2019--

PQ Bypass Inc, a medical device company bringing new advancements to the treatment of peripheral artery disease (PAD), 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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191219005715/en/

Heather Simonsen, General Manager of PQ Bypass (Photo: Business Wire)

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

View source version on businesswire.com:https://www.businesswire.com/news/home/20191219005715/en/

CONTACT: Victoria Versprille

Vversprille@pqbypass.com

+1-908-328-5787

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES CLINICAL TRIALS RESEARCH SCIENCE CARDIOLOGY BIOTECHNOLOGY

SOURCE: PQ Bypass Inc

Copyright Business Wire 2019.

PUB: 12/19/2019 03:15 PM/DISC: 12/19/2019 03:15 PM

http://www.businesswire.com/news/home/20191219005715/en