Sapheon Inc. tells us it has submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. FDA. Sapheon expects to be launching its product in the first half of 2015.
VenaSeal is a minimally invasive, single use kit which uses an endovascular adhesive to occlude vessels, thereby offering an alternative treatment for varicose veins (otherisw known as venous reflux).
This is the second time we’ve covered Sapheon’s VenaSeal system this month, the first being the announcement that it had raised sufficient funds to proceed through its FDA PMA application following completion of enrollment in its pivotal IDE study, tagged VeClose and covering 242 patients. The VeClose randomised study is intended to assess safety and effectiveness of the VenaSeal system compared with radiofrequency 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.”
Source: Sapheon, Inc., Business Wire