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

FDA application for varicose vein treatment

Sapheon : 24 September, 2013  (New Product)
Sapheon has submitted an application for approval from the FDA for the company's VenaSeal closure system for the treatment of patients suffering from varicose veins
FDA application for varicose vein treatment


Sapheon has submitted the first module of the pre-market approval (PMA) application for the VenaSeal Sapheon Closure System to the US Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015. VenaSeal is a minimally invasive, single use kit intended for the treatment of venous reflux (varicose veins) disease. The device is currently under clinical investigation in a 1:1 randomized pivotal study (the VeClose Study) to determine its safety and effectiveness compared to radio frequency thermal ablation.



“VenaSeal represents a novel approach to the treatment of venous reflux disease,” said Monte Madsen, Vice President, Clinical Affairs for Sapheon. “It is designed to eliminate the need for tumescent anesthesia by using our proprietary medical adhesive to close the great saphenous vein instead of heat to burn and destroy the vein.”



The VeClose Study is authorized under an investigational device exemption (IDE) approved by the FDA in December 2012. Clinical investigators at 10 sites in the US have treated 242 patients in the study. In addition to the VeClose Study, Sapheon is sponsoring two other VenaSeal studies: a 70-patient European post-market evaluation at seven sites within Germany, the UK, The Netherlands and Denmark that completed enrollment in September 2012; and a 38-patient feasibility study conducted in the Dominican Republic that completed enrollment in July 2011. The clinical data collected in these studies will be used to support the PMA application as well as to support product reimbursement activities in markets outside the United States.



The VenaSeal Sapheon Closure System received CE Mark approval in September 2011. Since that time, VenaSeal has been used to treat over 1,000 veins in patients in Europe and Hong Kong without tumescent anesthesia or the need for post-procedure compression hose therapy.


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