US-based Sapheon has submitted the first module of pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its VenaSeal sapheon closure system, designed to treat venous reflux (varicose veins) disease.
This PMA application submission places Sapheon on track for timely FDA review of VenaSeal, a minimally invasive, single use kit that is currently under clinical investigation in the VeClose study to determine its safety and effectiveness when compared to radio frequency thermal ablation.
In December 2012, the FDA had approved the VeClose Study under an investigational device exemption and a total of 242 patients have been treated at ten sites in this study.
Additionally, the company is also sponsoring two other VenaSeal studies at seven sites in Germany, the UK, the Netherlands and Denmark and the clinical data collected in these studies will be used by the company to support the PMA application as well as to support product reimbursement activities in markets outside the United States.
Sapheon clinical affairs vice president Monte Madsen noted 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 added.
The VenaSeal sapheon closure system received CE Mark approval in September 2011 and is expected to be launched in the first half of 2015.