As veins in the leg enlarge and become weaker, valves meant to maintain uni-directional blood flow begin to falter. This condition is known as venous reflux disease, and roughly 30 million people suffer from the symptomatic disease state in the United States alone. Aptly named Sapheon Medical has developed an alternative new technology to address venous reflux. Current treatment options, including vein stripping, radio frequency (RF) ablation, and sclerotherapy require surgery and can be traumatic or require compression hosing and don’t always have great outcome. The VenaSeal Sapheon Closure System uses a proprietary medical adhesive to close the saphenous vein, the largest superficial vein that runs from the foot to the groin. Upon closure, the body will adapt and reroute the blood into other parts of the vasculature, allowing the blood to return to the heart with minimal harmful effects on the patient. It will also remove the necessity of surgery, chemicals and sedatives, helping minimize recovery time.
The VenaSeal received CE mark approval in 2011, and over 1,000 patients have been successfully treated in Europe and Hong Kong with no anesthesia or compression hosing. Sapheon recently announced treatment of 242 patients in a U.S. clinical trial across 10 sites in the US. The study’s goal is to directly compare efficacy and safety relative to patients receiving RF ablation treatment, and the results are forthcoming.
Product page: VenaSeal Sapheon Closure System…
Press release: Sapheon Submits First Module of PMA Application for VenaSeal® Sapheon Closure System…