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September 21, 2011
Sapheon Receives CE Mark Approval for Varicose Vein Treatment
September 22, 2011—Sapheon Inc. (Santa Rosa, CA) announced that it has received CE Mark approval for the Sapheon closure system to treat varicose veins caused by venous reflux disease. The device uses the company's medical adhesive and single-use catheter-based delivery system to achieve immediate and permanent saphenous vein closure without thermal ablation or sclerosing chemicals.
According to the company, patients treated with the Sapheon closure system do not experience significant postprocedure pain and bruising, do not need to wear compression stockings, and can immediately resume normal lifestyle activities. In contrast to thermal ablation procedures, Sapheon treatment does not require tumescent anesthesia or patient sedation.
The company stated that distribution of the Sapheon closure system within the European Union will commence in the fourth quarter of 2011. The company plans to initiate the eSCOPE (European Sapheon Closure System Observational Prospective) postmarket study in Europe starting in November 2011. The company also advised that it will be presenting the Sapheon closure system at the US Food and Drug Administrations' Tissue Adhesives Symposium on September 26 and 27, 2011.
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