Vessix Vascular has obtained CE mark approval for its V2 renal denervation system for the treatment of hypertension.
The V2 system is an over-the-wire, balloon catheter with electrodes and thermistors mounted on the exterior of the balloon and by using RF balloon catheter technology, it delivers RF energy within 30 seconds per artery.
Vessix Vascular CEO Raymond Cohen said the company has provided an approach to treat uncontrolled hypertension which is easier to use and less painful for patients than any renal denervation system currently available in the market.
"After eight years optimizing RF balloon catheter and bipolar RF generator technologies, it is rewarding to see the V2 System working effectively in clinical practice to safely reduce patient blood pressures," Cohen added.
"As part of our commercialization strategy, Vessix has initiated a post-market approval surveillance study during which we plan to treat 120 patients at up to 20 international centers located across Western Europe."
Vessix chief commercialization officer Michael Gioffredi said the company looks forward to share additional pre-clinical and human data at upcoming EuroPCR Conference held in Paris, France, from15-18 May 2012.