SANTA ROSA, Calif.--(BUSINESS WIRE)--Sapheon Inc. announced successful enrollment in a 30-patient, prospective, single-arm clinical study of the Sapheon Closure System — a single-use, minimally invasive approach to the treatment of saphenous vein reflux disease. The Sapheon Closure System consists of a proprietary vein sealant and custom delivery system that eliminates the need for painful and time consuming deep tissue injections of tumescent anesthesia. The procedure is performed under ultrasound imaging guidance and requires only local anesthesia at the catheter entry site. The study was conducted by leading physician-investigators from the United States and Germany at the Clinica Canela in the Dominican Republic under local bio-ethics committee and government approvals as well as U.S. Food and Drug Administration clinical trial export permitting. The fully monitored study is overseen by a U.S.-based Data Safety Monitoring Board and is being conducted to support the international regulatory approvals and marketing efforts of the Company.
