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TMCNet:  Sapheon VenaSeal® Receives Health Canada Approval; First Cases Performed in Vancouver and Toronto

[January 28, 2014]

Sapheon VenaSeal® Receives Health Canada Approval; First Cases Performed in Vancouver and Toronto

MORRISVILLE, N.C. --(Business Wire)--

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. Over 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 Drs. Joel Gagnon and David Liu in Vancouver and Drs. David Szalay and Ted Rapanos in Toronto. Nine patients were successfully treated with 100% 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 Drs. 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."

Drs. Szalay and Rapanos are vascular surgeons with Oakville Vascular, one of Canada's largest vein reatment centers. According to Dr. 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. We are proud to be one of the first centers in North America to offer this treatment to our patients."


"We are fortunate to receive early support from leading Canadian physicians in vein care," said Nate Raabe, Canada Sales Manager. "We have seen excellent clinical results in patients throughout Europe and look forward to expanding VenaSeal's availability in Canada."

VenaSeal is currently 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 an FDA-approved investigational device exemption (IDE), has clinical investigators at 10 sites in the U.S. 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 over 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.

ABOUT SAPHEON

Sapheon Inc. is a privately held medical device company whose mission is to develop new approaches and disruptive technologies for the treatment of vascular disease. The Company's current focus is on an advanced treatment for venous reflux disease, a condition requiring over 550,000 surgical procedures worldwide in 2012. The VenaSeal Sapheon Closure System is not commercially available in the United States. www.sapheoninc.com


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