Vessix Receives CE Mark Approval for V2 Renal Denervation System
May 1, 2012—Vessix Vascular, Inc. (Laguna Hills, CA) announced that it has received CE Mark approval for its V2 renal denervation system for the treatment of hypertension. The company has initiated a postmarket approval surveillance study that plans to treat 120 patients at up to 20 centers located across western Europe.
The percutaneous V2 system for the treatment of uncontrolled hypertension is an over-the-wire balloon catheter with an array of radiofrequency (RF) electrodes mounted in a precise pattern. The electrodes are designed to deliver a modest dose of RF energy to disrupt the renal nerves located in the adventitia that surround the renal artery, according to the company. The Vessix RF balloon catheter connects to a bipolar RF generator that is designed for the renal denervation clinical application.
The V2 balloon catheter occludes blood flow to the renal artery during the 30-second RF therapy delivery, providing a directed and highly controlled flow of heat energy to the target nerves. Rapid RF treatment time greatly increases the efficiency of the denervation procedure and provides safety benefits for the clinician and the patient in terms of lower use of contrast dye and less radiation exposure, stated the company.
Vessix advised that Prof. Uta Hoppe, MD, will present interim clinical results from the company’s pilot REDUCE-HTN clinical study at the EuroPCR 2012 conference in Paris. The presentation will be made during the "Emerging Interventional Technologies for Treatment of Resistant Hypertension" session to be held from 8:00–10:20 am on May 17 in Room 241 at the Palais des Congres de Paris.
Prof. Hoppe will present 1-month post-treatment safety and efficacy data from her patients treated at Paracelsus Medical University in Salzburg, Austria, and patients treated at Georges Pompidou Hospital in Paris, France and OLV Ziekenhuis in Aalst, Belgium. Horst E. Sievert, MD, is Principal Investigator of the REDUCE-HTN trial.