Vascular device company Sapheon Inc. tells us it has submitted the second module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. FDA. The submission, which was completed on December 18, 2013, represents steady progress on the modular PMA application for VenaSeal, a minimally invasive, single use kit intended for the treatment of venous reflux (varicose veins) disease.
The VenaSeal Sapheon Closure System received CE Mark approval in September 2011, since when it 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.
VenaSeal 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. 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 and was fully enrolled in September 2013. The company expects the 3-month assessments of patients enrolled in the VeClose Study to be completed this month and the study’s primary efficacy end-point of vein closure, as adjudicated by an independent core laboratory, to be reported shortly thereafter.
The first module, submitted in September 2013, as reported here, was reviewed by the FDA and accepted without deficiencies within a single review cycle.
Sapheon is also 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 company has agreed to continue to follow the patients in these two studies for a period of three years. The clinical data collected in these studies will be used to support the PMA application as well as reimbursement in markets outside the United States.
“2013 was an exciting year for Sapheon,” said Don Crawford, President and CEO. “In 2014, the focus for our team is on preparations for a 2015 U.S. product launch and eventual market leadership in the treatment of venous reflux disease.”
Source: Sapheon, Inc., Business Wire