Medical device developer Sapheon has filed for regulatory approval of a new device to treat varicose veins.
The Morrisville company said that the first module of its VenaSeal device has been submitted to the Food and Drug Administration for pre-market approval. The filing comes on the heels of raising $19.8 million in financing, which closed in early September.
Sapheon said that it expects to launch VenaSeal in the first half of 2015.
VenaSeal is a minimally invasive device developed to treat venous reflux disease, more commonly called varicose veins. An estimated 550,000 surgical procedures were done worldwide in 2012 to treat the condition. Sapheon’s device uses a proprietary medical adhesive to close the saphenous vein, which eliminates the need of a surgical procedure employing heat to burn and destroy the vein.
While VenaSeal still awaits FDA approval, it is already approved in Europe. Since receiving the European CE Mark in 2011, Sapheon says that its device has been used to treat more than 1,000 veins in patients in Europe and Hong Kong.
The VenaSeal has been studied in trials at 10 sites in the United States treating 242 patients. In addition to those studies, Sapheon said it is sponsoring two other VenaSeal studies. The first is a 70-patient European post-market evaluation at seven sites in Germany, the United Kingdom, the Netherlands and Denmark. The second study is a 38-patient feasibility study in the Dominican Republic. Clinical data from all of the studies will be used to support Sapheon’s application for approval with the FDA and also to support the company’s case to payers for reimbursement.
