Sapheon has reported one year data in its European multicenter clinical study of the VenaSeal sapheon closure system, designed to treat venous reflux disease (varicose veins).
By using a specially formulated medical adhesive, the VenaSeal system closes the saphenous vein. In addition, the system avoids the need for surgery, thermal ablation, sedatives, and tumescent anesthesia.
The single-arm, multi-center post-market study involves nine physicians at seven sites treating 70 patients from the UK, Germany, Demark and The Netherlands.
All patients were treated without tumescent anesthesia or post-procedure compression stockings, and will be followed for two years.
All treatments were successful and a closure rate of 94.3% was observed at six months. No additional recanalization was observed at one year follow-up (n=66).
Sapheon president and CEO Don Crawford said the company is pleased that the one year results of the European study are consistent with and confirmatory of the one year results in our feasibility trial.
"This evidence of durability enables us to move forward with the planned 2015 introduction of VenaSeal in the U.S. with the confidence that we have developed an alternative to thermal ablation that results in greater patient satisfaction," Crawford added.
The VenaSeal sapheon closure system received CE Mark approval in September 2011.
In the US, the VenaSeal sapheon closure system is currently under clinical investigation in the VeClose study.
The randomized pivotal study is designed to assess the safety and effectiveness of VenaSeal system compared with radiofrequency thermal ablation.
The VeClose study, authorized under an US Food and Drug Administration-approved investigational device exemption (IDE), has clinical investigators at ten sites in the US for the treatment of 242 study patients. The study was fully enrolled in September 2013.