Sapheon Inc. has received CE Mark approval for its new approach to the treatment of varicose veins caused by venous reflux disease. The Sapheon Closure System addresses the estimated one million procedures performed each year to close the great saphenous vein. Sapheon’s technology uses an advanced proprietary medical adhesive and single-use catheter-based delivery system to immediately and permanently achieve vein closure without thermal ablation or sclerosing chemicals. Patients treated with the Sapheon Closure System avoid significant post procedure pain and bruising, do not need to wear compression stockings, and can immediately resume normal lifestyle activities.
Unlike current thermal ablation procedures, the Sapheon treatment does not require tumescent anesthesia or patient sedation.
“Treatment of incompetent great saphenous vein segments with the Sapheon technology is safe and effective,” according to Dr. Thomas Proebstle of Mannheim, Germany, a clinical investigator and early adopter of the Sapheon Closure System. “It is a welcome and exciting improvement over existing vein closure technologies.”
“We are pleased to receive the regulatory go-ahead to introduce our product to physicians and patients in the European Union and other countries outside the U.S.,” said Don Crawford, President and CEO of Sapheon. “We believe that the Sapheon approach is the future of vein disease treatment.”
Distribution of the Sapheon Closure System within the EU will commence in the fourth quarter of 2011. The Company plans to initiate a post-market study — the European Sapheon Closure System Observational ProspectivE (eSCOPE ) Trial — in the EU starting in November 2011.
Sapheon will be presenting the Sapheon Closure System at the FDA Tissue Adhesives Symposium to be held at the FDA White Oak Campus in Silver Spring, Maryland, September 26-27, 2011.
Sapheon is an early stage medical device company whose mission is to develop new approaches for the treatment of vascular disease. Our current focus is on technology to improve the treatment of varicose veins caused by venous reflux disease. Please visit www.sapheoninc.com to learn more about our business.