PQ Bypass said today that it won full FDA approval of its investigational device exemption trial for the Torus stent graft for treating peripheral artery disease.
The Torus stent graft is designed to treat PAD in the superficial femoral artery by aiding in halting the progression of the disease, rather than solely treat the symptoms, which can allow the disease to advance. The Torus won CE Mark approval in March 2017 as a part of the Detour percutaneous femoropopliteal bypass system procedure.
The Torus-2 study will be the company’s second IDE approved in less than two years and it is the first pivotal IDA for an SFA stent graft since Viabahn won initial pre-market approval in 2005, according to a news release.
PQ Bypass said it will begin enrollment in the fourth quarter of 2019, as it was approved for up to 188 subjects for the prospective, single-arm study.
“We have developed a robust technology, which is currently being studied in our Detour-2 percutaneous bypass IDE,” SVP & GM Heather Simonsen said in prepared remarks. “Now we are expanding our focus to also address SFA lesions earlier in the disease process to target a market that currently has only one entry.”
“This is an incredible win, on the part of every member of the PQ Bypass family,” added CEO & chairman of the board Rich Ferrari. “It really speaks to the quality of the work we have done as a company, both internally and in our clinical trials, as well as the Torus stent graft itself. All of us at PQ are excited about running two pivotal IDE studies that are aiming to provide treatment for such a large and under-served population.”