Sapheon VenaSeal Receives Health Canada Approval

Sapheon Inc. announced it has received approval from Health Canada for the VenaSeal Sapheon Closure System, a new treatment for venous reflux disease (varicose veins). VenaSeal uses a specially formulated medical adhesive to close the saphenous vein, eliminating the need for surgery, thermal ablation, sedatives, and tumescent anesthesia. More than 550,000 surgical procedures are performed around the world each year to treat diseased saphenous veins.

The first VenaSeal cases in Canada were performed by Joel Gagnon, M.D., and David Liu, M.D., in Vancouver, and David Szalay, M.D., and Ted Rapanos, M.D., in Toronto. Nine patients were successfully treated with 100 percent vein closure. No tumescent anesthesia or post treatment compressions stockings were used.

“The minimally invasive nature, rapid recovery, and excellent results of VenaSeal represent a revolution in vein care,” said Gagnon and Liu. “We have had extensive experience in vein therapy platforms at Eva Vein Care. VenaSeal has the potential to become the leading technology in the management of varicose veins.”

Szalay and Rapanos are vascular surgeons with Oakville Vascular, one of Canada’s largest vein treatment centers. According to Rapanos, “Our early results show VenaSeal to be an effective option for treating varicose veins. The procedure does not require multiple injections of anesthesia or post-op compression stockings, making it a more comfortable experience for the patient. Patients are able to immediately return to their normal activities after treatment.”

VenaSeal currently is under clinical investigation in the United States in a 1:1 randomized pivotal study (the VeClose Study) to determine its safety and effectiveness compared to radiofrequency thermal ablation. The VeClose Study, authorized under a U.S. Food and Drug Administration-approved investigational device exemption, has clinical investigators at 10 sites in the United States for the treatment of 242 study patients. The study was fully enrolled in September 2013.

The VenaSeal Sapheon Closure System received CE Mark approval in September 2011. Since that time, VenaSeal has been used to treat more than 1,700 veins in patients in Europe and Hong Kong without tumescent anesthesia or post-procedure compression hose therapy. At this time, the VenaSeal Sapheon Closure System is limited to investigational use within the United States.

Sapheon Inc. is a privately held medical device company that develops vascular disease treatment. The company is based in Morrisville, N.C.