FDA Grants IDE Approval for Pivotal Trial of PQ Bypass' Torus SFA Stent Graft

October 8, 2019—PQ Bypass, Inc. announced it has received full approval for its investigational device exemption (IDE) trial of the Torus stent graft for the treatment of peripheral artery disease in the superficial femoral artery.

TORUS-2 is the PQ Bypass pivotal IDE intra-arterial stent graft study for occlusive and restenotic femoropopliteal revascularization. Enrollment in the prospective, single-arm, global multicenter study will begin in Q4 of 2019. The study has been approved to enroll up to 188 patients at up to 40 sites.

This is the company’s second IDE approved in less than 2 years. The TORUS-2 IDE will allow the company to acquire early FDA feedback through the presubmission process.

According to the company, the TORUS-2 IDE approval follows the recent approval for the DETOUR-2 pivotal trial, which is evaluating the safety and effectiveness of the company’s Detour system to create a percutaneous femoropopliteal bypass. The DETOUR trial, which is currently underway, will enroll up to 292 patients at up to 40 sites across the United States and Europe. The DETOUR study’s national Coprincipal Investigators are Sean Lyden, MD, and Jihad Mustapha, MD. In March 2017, PQ Bypass received European CE Mark approval for the Detour system.

The Torus stent graft received European CE Mark approval as a part of the Detour procedure in March 2017.