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Sapheon, Inc. Submits First Module of PMA Application for VenaSeal® Sapheon Closure System


9/20/2013 11:00:13 AM

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MORRISVILLE, N.C.--(BUSINESS WIRE)--Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015. VenaSeal is a minimally invasive, single use kit intended for the treatment of venous reflux (varicose veins) disease. The device is currently under clinical investigation in a 1:1 randomized pivotal study (the VeClose Study) to determine its safety and effectiveness compared to radio frequency thermal ablation.

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