PQ Bypass has received full approval of its investigational device exemption (IDE) trial (TORUS 2) of its Torus stent graft, which is a novel stent graft platform designed for the treatment of peripheral arterial disease in the superficial femoral artery. By acquiring early FDA feedback through the presubmission process, the TORUS-2 study (The PQ Bypass pivotal IDE intra-arterial stent graft study for occlusive and re-stenotic fempop revascularisation) is the company’s second IDE approved in less than two years and is the first pivotal IDE for a superficial femoral artery stent graft since Viabahn received initial premarket approval (PMA) approval in 2005.
The company will begin enrolling in the prospective, single-arm, global multicentre study in Q4 of 2019. The study has been approved to enrol up to 188 patients at up to 40 sites. The Torus stent graft received CE mark as a part of the DETOUR procedure in 2017. A press release reports that having been exposed to the Torus stent graft in the context of the DETOUR procedure, increasing demand is being vocalised to have this same stent graft studied for its safety and efficacy within the superficial femoral artery as an intra-arterial stent graft.
Heather Simonsen, senior vice president and general manager of PQ Bypass, comments: “We have developed a robust technology, which is currently being studied in our DETOUR-2 percutaneous bypass IDE. Now we are expanding our focus to also address superficial femoral artery lesions earlier in the disease process to target a market that currently has only one entry.”
Rich Ferrari, CEO and chairman of the board, states: “This is an incredible win, on the part of every member of the PQ Bypass family. 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.”
The Torus stent graft is limited by federal law to investigational use only and is not available for sale in the USA.