Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

Canadian approval for varicose vein treatment

Sapheon : 03 February, 2014  (Application Story)
The VenaSeal Sapheon Closure System for the treatment of varicose veins has been approved by Health Canada
Canadian approval for varicose vein treatment


Sapheon 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 treatment centres. 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 centres 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.


Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo