On 1 May 2012, Vessix Vascular, a developer of novel percutaneous radiofrequency balloon catheter technology for the treatment of hypertension, announced that it has received CE mark approval for its V2 Renal Denervation System for the treatment of hypertension.
Renal denervation is a percutaneous, catheter-based therapy that uses radiofrequency 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 optimising radiofrequency balloon catheter and bipolar radiofrequency 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 commercialisation 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.”
Renal denervation has shown in published clinical studies to be safe, durable and effective in reducing systolic blood pressure by approximately 20%.
Michael D Gioffredi, Vessix’s chief commercialisation 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 multicentre European pilot study, we are moving forward with our commercialisation plans in Europe and we look forward to sharing additional pre-clinical and human data at upcoming medical conferences in support of that launch.”
Vessix will present interim clinical results from its pilot REDUCE-HTN clinical study for patients with uncontrolled hypertension at EuroPCR 2012.
Uta Hoppe, Paracelsus Medical University in Salzburg, Austria, will present one-month post-treatment safety and efficacy data from her patients treated at Paracelsus and additional patients treated at Georges Pompidou Hospital in Paris, France, and OLV Ziekenhuis in Aalst, Belgium. The presentation will be made during the “Emerging Interventional Technologies for Treatment of Resistant Hypertension” at 8:00–10:20am local time on Thursday, 17 May in Room 241 at the Palais des Congres de Paris.
About the Vessix V2 Renal Denervation System
- The V2 System for the treatment of uncontrolled hypertension is an over-the-wire balloon catheter with an array of radiofrequency electrodes mounted in a precise pattern designed to deliver a modest dose of radiofrequency energy to disrupt the renal nerves located in the adventitia that surround the renal artery. The patented radiofrequency balloon catheter connects to a proprietary bipolar radiofrequency generator specifically designed and optimised for the renal denervation clinical application.
- Therapy is delivered via a balloon catheter that is quite familiar to interventional cardiologists and other physicians, thereby increasing the usability and safety profile of the device.
- The V2 balloon catheter occludes blood flow to the renal artery during the 30-second radiofrequency therapy delivery allowing for a directed and highly controlled flow of heat energy to the target nerves. Consequently, the V2 is significantly faster – by an order of magnitude – than other renal denervation systems currently marketed.
- Rapid radiofrequency treatment time greatly increases the efficiency of the denervation procedure and additional safety benefits to the clinician conducting the procedure and the patient in terms of less use of contrast dye and lower exposure to radiation.