Sapheon has reported one year follow-up data from its European multicentre clinical study of the VenaSeal sapheon closure system, an advanced approach to the treatment of venous reflux (varicose veins) disease based on a proprietary medical adhesive and delivery system.
Conducted at seven sites, 70 patients from the UK, Germany, Demark and the Netherlands have been treated in the single-arm, post-market study. A total of nine physicians were involved in this study.
In this study, all patients were treated without tumescent anesthesia or post-procedure compression stockings, and will be followed for two years.
According to the company, all treatments were successful and a closure rate of 94.3% was observed at six months. No additional recanalisation was observed at one year follow-up.
Sapheon president and CEO Don Crawford said: "This evidence of durability enables us to move forward with the planned 2015 introduction of VenaSeal in the US with the confidence that we have developed an alternative to thermal ablation that results in greater patient satisfaction."
In the US, the VenaSeal sapheon closure system is currently under clinical investigation in the US Food and Drug Administration’s investigational device exemption approved VeClose study.
VeClose is a 1:1 randomised pivotal study designed to assess the safety and effectiveness of the VenaSeal system compared to radiofrequency thermal ablation.
The study was fully enrolled in September 2013, with clinical investigators at ten sites in the US for the treatment of 242 study patients.
Sapheon obtained CE Mark approval for the VenaSeal sapheon closure system in September 2011. Since approval, the device 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.
Image: Sapheon’s VenaSeal system for treatment of venous reflux disease. Photo: courtesy of Businesswire/Sapheon Inc.