We’ve been watching Sapheon’s novel VenaSeal® varicose vein treatment system as it gathers momentum in the form of clinical trials and modular PMA application in the United States. Now the company has announced one year data in its European multicenter clinical study of the system.
Background
VenaSeal is an advanced approach to the treatment of venous reflux (varicose veins) disease based on a proprietary medical adhesive and delivery system. The company’s 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 2 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).
VenaSeal is an investigatve device in the United States, undergoing a 1:1 randomized pivotal study (the VeClose Study) to determine its safety and effectiveness compared to radiofrequency 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. That study was fully enrolled in September 2013.
The VenaSeal Sapheon Closure System received CE Mark approval in September 2011. Since that time, Sapheon tells us the product 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.
Physician comments
According to the study’s co-principal investigator, Prof. Dr. Thomas Proebstle of Mainz University, Germany, “Cyanoacrylate embolization is proving to be an effective and durable solution to the problem of incompetent great saphenous veins. Long-term effectiveness is high. The elimination of the need for perivenous tumescent anesthesia and post-interventional compression stockings, along with the associated side effects, results in significantly improved treatment.”
Company comments
Don Crawford, President and CEO of Sapheon, stated, “We are 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.”
Source: Sapheon, Inc., Business Wire
published: February 28, 2014 in: Clinical Studies/Trials, Vascular