1 May 2012
Vessix receives CE Mark for V2 Renal Denervation Systemô for treatment of hypertension
Vessix Vascular, Inc., a developer of novel percutaneous radiofrequency (RF) balloon catheter technology for the treatment of hypertension, announced today that it has received Conformité Européenne (CE) Mark approval for its V2 Renal Denervation System™ for the treatment of hypertension. Renal denervation is a percutaneous, catheter-based therapy that uses RF energy to disrupt renal sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure.
The CE Mark enables Vessix to market its patented V2 System throughout the European Union. The CE certification was issued to Vessix by its notified body, BSI Group, also known as the British Standards Institution.
“Vessix offers a unique approach to treating uncontrolled hypertension that provides excellent clinical results and is faster, easier to use and less painful for patients than any renal denervation system currently available in the market,” said CEO Raymond W. Cohen. “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. 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."
Hypertension is the leading attributable cause of death worldwide. According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease and a 7 percent decrease in overall mortality. Renal denervation has shown in published clinical studies to be safe, durable and effective in reducing systolic blood pressure by approximately 20 percent.
Michael D. Gioffredi, Vessix’s Chief Commercialization Officer said, “Renal denervation is rapidly becoming one of the most important medical device developments in decades and we believe that our unique design will set a new standard for the treatment. In light of this regulatory clearance and the strong early clinical results from our multi-center European pilot study, we are moving forward with our commercialization plans in Europe and we look forward to sharing additional pre-clinical and human data at upcoming medical conferences in support of that launch.”