Sapheon secured approval from Health Canada for its VenaSeal Sapheon closure system, used in the treatment of varicose veins.
Morrisville, N.C.-based Sapheon develops treatments for vascular disease, its flagship product being the VenaSeal, a medical adhesive which seals blood vessels using a special glue. The company is currently working towards getting pre-market approval from the U.S. FDA.
Sapheon hopes to use revenues from Canadian sales to support regulatory efforts in the U.S. The device has already been used to successfully treat 9 patients in Toronto and Vancouver, according to a press release.
“We are fortunate to receive early support from leading Canadian physicians in vein care. We have seen excellent clinical results in patients throughout Europe and look forward to expanding VenaSeal’s availability in Canada,” Canada sales manager Nate Raabe said in prepared remarks.