SANTA ROSA -- Sapheon Inc., a medical device maker that develops treatments for vascular disease, announced that it has received approval in Europe for its approach to the treatment of varicose veins caused by venous reflux disease.
The Sapheon Closure System addresses the estimated 1 million procedures performed each year to close the great saphenous vein.
Sapheon said its technology uses an advanced proprietary medical adhesive and single-use catheter-based delivery system to immediately and permanently achieve vein closure without thermal ablation.
The Closure System allows patients treated with it to avoid significant post procedure pain and bruising, according to Sapheon. Patients also do not need to wear compression stockings, and can immediately resume normal lifestyle activities, the company said.
The Sapheon treatment does not require anesthesia or patient sedation.
"Treatment of incompetent great saphenous vein segments with the Sapheon technology is safe and effective," Dr. Thomas Proebstle of Mannheim, Germany, a clinical investigator, said in a statement. "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 begin in the fourth quarter of 2011. The company plans to initiate a post-market study -- the European Sapheon Closure System Observational Prospective Trial -- in the EU starting in November.
The company, founded in 2007, has a total of 29 employees and consultants (16 full-time employees) that are managed out of the Santa Rosa headquarters.
It is also opening an office in Research Triangle Park, N.C., to support its Amsterdam operating subsidiary, Sapheon Vascular B.V. and is hiring engineers, clinical managers and sales associates in the UK and Netherlands, according to Vice President of Finance and Administration Harry Phillips.