Sapheon has obtained Health Canada approval for its VenaSeal sapheon closure system, designed to treat venous reflux disease.
Morrisville, N.C. - By using a specially formulated medical adhesive, Sapheon's VenaSeal system closes the saphenous vein. In addition, the system avoids the need for surgery, thermal ablation, sedatives, and tumescent anaesthesia.
In Canada, Dr. Joel Gagnon and Dr. David Liu in Vancouver, and Dr. David Szalay and Dr. Ted Rapanos in Toronto, have performed the first VenaSeal cases.
So far, nine patients have been successfully treated with 100% vein closure and no tumescent anesthesia or post treatment compressions stockings were used.
Sapheon Canada sales manager Nate Raabe said: “We have seen excellent clinical results in patients throughout Europe and look forward to expanding VenaSeal's availability in Canada.”
In the United States, the VenaSeal sapheon closure system is currently under clinical investigation in the VeClose study. The randomised pivotal study is designed to assess the safety and effectiveness of VenaSeal system compared with radiofrequency thermal ablation.
The VeClose study, authorized under an U.S. Food and Drug Administration-approved investigational device exemption (IDE), has clinical investigators at ten sites in the US for the treatment of 242 study patients. The study was fully enrolled in September 2013.
Since receiving CE mark approval in September 2011, the VenaSeal sapheon closure system 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.
The VenaSeal sapheon closure system is yet not commercially available in the U.S.