US-based Sapheon has submitted its first pre-market approval (PMA) module to the US Food and Drug Administration (FDA) for VenaSeal sapheon closure system, which is designed for the treatment of varicose veins caused by venous reflux disease.
The VenaSeal sapheon closure system is a minimally invasive, single use kit for the treatment of varicose veins.
The VenaSeal sapheon closure system was designed to address invasive and painful surgery or ablation procedures. It consists of a proprietary vein sealant and custom delivery system that eliminates the need for painful and time-consuming deep tissue injections of tumescent anaesthesia.
Sapheon clinical affairs vice-president Monte Madsen said VenaSeal represents a novel approach to the treatment of venous reflux disease.
"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," Madsen said.
According to Sapheon, treatment with the VenaSeal system provides better patient outcomes as the procedure is performed under ultrasound imaging guidance, it has a high patient tolerance and requires only local anaesthesia at the catheter entry site.
The safety and effectiveness of the device as against radio frequency thermal ablation is currently being evaluated in a 1:1 randomised pivotal study (the VeClose) at 10 US clinical sites.
The VeClose study, authorised under an investigational device exemption (IDE) by the FDA in December 2012, has treated 242 patients.
In addition to this study, Sapheon is sponsoring a 70-patient European post-market evaluation study that completed enrolment in September 2012 and a 38-patient feasibility study conducted in the Dominican Republic, which that completed enrolment in July 2011.
The company is planning to use the clinical data collected in these studies to support its PMA application, as well as to support product reimbursement activities in markets outside the US.
With the PMA submission in place on time, Sapheon hopes to launch VenaSeal in the first half of 2015.
Earlier in September 2011, the VenaSeal received CE Mark approval in Europe and since then it has been used to treat over 1,000 veins in patients in Europe and Hong Kong.
Image: The VenaSeal sapheon closure system. Photo: courtesy of Business Wire.