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Medical Devices / Submissions and Approvals

PQ Bypass Wins IDE Approval for First-of-Its-Kind Pivotal Trial

Dec. 14, 2017
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Silicon Valley-based medical device company PQ Bypass received an investigational device exemption to launch the first ever pivotal trial for percutaneous femoropopliteal bypass.

The DETOUR II system’s procedure for treating lower limb ischemia caused by peripheral artery disease is an “entirely new procedure” in which a pathway is created in the superficial femoral artery that bypasses the diseased part, the company said.

The procedure’s safety and effectiveness will be evaluated at up to 40 trial sites in support of the company’s PMA submission to the FDA.

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