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It might be cliché to say here comes a new challenger – but in the case of PQ Bypass it’s quite true.
The Milpitas, CA-based firm said it will be the first company since 2004 to have an IDE trial for a stent to treat peripheral artery disease in the superficial femoral artery (SFA). The other company to have an SFA IDE trial is W.L. Gore. The Newark, DE-based company would eventually win a nod from FDA for the Viabahn system.
PQ Bypass made a major advancement in its bid to get the Torus Stent Graft on the market last week as the company reported it received approval for coverage of the IDE from the Centers for Medicare and Medicaid Services. The TORUS 2 IDE is expected to enroll up to 188 patients in 40 sites. FDA greenlit the IDE trial in October.
Heather Simonsen, General Manager of PQ Bypass explained how the CMS coverage could impact the IDE trial.
“Why the [CMS approval] is important is because it makes it easier for the investigational sites in the U.S. to actually participate in the study,” Simonsen, told MD+DI. “It will help to expedite the research and it will certainly provide more options in terms of things like site selection. Sometimes sites won’t participate if there isn’t CMS coverage in an IDE. It’s a big thing particularly for a venture-funded company.”
She added, “We expect to enroll this trial pretty rapidly. By the end of this year, we expect to fully enroll this study. There has been a lot of demand. We have another IDE that we’re running called DETOUR 2 and every single site has asked if they can participate in TORUS 2.”
Simonsen noted the company would be potentially filing the PMA for Torus in 2021.
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. 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.
PQ Bypass has strong financial backing to help it going forward. The firm raised $60 million in a series C round last year and is in a relatively good position. Simonsen said the company’s solutions are coming at the right time and the market is big enough for the Torus system and Gore’s Viabahn.
“I think the market is big enough [for both companies],” she said. “There hasn’t been a new technology on the market for a covered-stent with an SFA indication for nearly 15+ years.”