News | Stent Grafts | October 08, 2019

PQ Bypass Granted IDE Approval to Start TORUS SFA Stent Graft Pivotal Study

TORUS-2 marks second Investigational Device Exemption approved for company in less than two years

PQ Bypass Granted IDE Approval to Start TORUS SFA Stent Graft Pivotal Study

October 8, 2019 — PQ Bypass Inc. announced it has received full approval of its investigational device exemption (IDE) trial of the company’s Torus stent graft. The novel stent graft platform is designed for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). By acquiring early U.S. Food and Drug Administration (FDA) feedback through the pre-submission process, the TORUS-2 study (The PQ Bypass pivOtal IDE intra-aRterial stent graft study for occlUsive and re-Stenotic fem-pop revascularization) is the company’s second IDE approved in less than two years and is the first pivotal IDE for an SFA stent graft since Viabahn received initial premarket approval (PMA) in 2005.

The TORUS-2 IDE approval comes close on the heels of the approval for the DETOUR-2 trial. Having been exposed to the Torus stent graft in the context of the DETOUR procedure, increasing demand is being vocalized to get this same stent graft studied for its safety and efficacy within the SFA as an intra-arterial stent graft.

Read the article "PQ Bypass Effective in Treating Extremely Long SFA Lesions at 12 Months"

PAD, left under- or untreated, can deteriorate the body’s vascular system to the point of rest pain, amputation and even death. Current therapies, such as balloon angioplasty, atherectomy and bare metal stents, frequently do not provide satisfactory long-term patency and will often require cyclical re-treatment. Stent grafts, unlike bare metal stents, aid in halting the progression of PAD, rather than solely treating the symptoms and allowing the disease to advance.

The company will begin enrolling in the prospective, single-arm, global multicenter study in Q4 of 2019. The study has been approved to enroll up to 188 subjects at up to 40 sites. The Torus stent graft received CE Mark as a part of the DETOUR procedure in 2017.

For more information: www.pqbypass.com

Related Content

News | Cardiovascular Clinical Studies

June 24, 2021 — Data captured in American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ...

Home June 24, 2021
Home
News | Cardiovascular Clinical Studies

January 27, 2021 — A New York Institute of Technology research team has secured a five-year $1.8 million grant from the ...

Home January 27, 2021
Home
News | Cardiovascular Clinical Studies

July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to ...

Home July 22, 2020
Home
News | Cardiovascular Clinical Studies

July 1, 2020 — Carag AG announced receiving U.S. Food and Drug Administration (FDA) Investigational Device Exemption ...

Home July 01, 2020
Home
News | Cardiovascular Clinical Studies

January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special ...

Home January 20, 2020
Home
News | Cardiovascular Clinical Studies

Environmental and lifestyle issues were popular this year, with pick up from both European Society of Cardiology (ESC) ...

Home December 23, 2019
Home
News | Cardiovascular Clinical Studies

November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have ...

Home November 26, 2019
Home
News | Cardiovascular Clinical Studies

July 10, 2019 — The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During ...

Home July 10, 2019
Home
News | Cardiovascular Clinical Studies

July 3, 2019 — The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to ...

Home July 03, 2019
Home
News | Cardiovascular Clinical Studies

November 19, 2018 — The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent ...

Home November 19, 2018
Home
Subscribe Now