PQ Bypass Inc. announced it has received full approval of its investigational device exemption (IDE) trial of the companyโs 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 companyโs 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.
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