Sapheon Inc. said it’s taken the 1st step toward getting its VenaSeal Sapheon varicose vein device on the U.S. market, filing the 1st module in its pre-market approval application with the FDA.
"The submission places Sapheon on track for timely FDA review and expected product launch in the 1st half of 2015," according to a press release.
The VenaSeal device is designed to seal blood vessels using a special glue developed by Morrisville, N.C.-based Sapheon. The company is conducting a U.S. investigational device exemption trial of 242 patients, according to the release, and has a pair of other studies under way in Europe and the Dominican Republic, totaling 108 patients. The VenaSeal device won CE Mark approval in the European Union in 2011.
"VenaSeal represents a novel approach to the treatment of venous reflux disease," clinical affair vice president Monte Madsen said in prepared remarks. "It is designed to eliminate the need for tumescent anesthesia by using our proprietary medical adhesive to close the great saphenous vein instead of heat to burn and destroy the vein."