Just two days after we reported on the design story behind the Vessix V2 renal denervation system,Vessix Vascular is now announcing it has received European CE Mark approval for its percutaneous radiofrequency balloon catheter technology for the treatment of hypertension. According to the company, the system is faster, easier to use and less painful for patients than any renal denervation system currently available on the market.
The V2 is approved for use in patients with uncontrolled hypertension despite taking three or more anti-hypertensive medications. In these patients, renal denervation may reduce systolic blood pressure by approximately 20 percent, thereby greatly reducing the risk of stroke and cardiovascular disease.
Vessix will be presenting initial results from its pilot REDUCE-HTN clinical study with the device at the EuroPCR conference in Paris on May 15-18. A short overview of the system, from the press release:
The V2 System for the treatment of uncontrolled hypertension is an over-the-wire balloon catheter with an array of RF electrodes mounted in a precise pattern designed to deliver a modest dose of RF energy to disrupt the renal nerves located in the adventitia that surround the renal artery. The patented RF balloon catheter connects to a proprietary bipolar RF generator specifically designed and optimized 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 RF 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 RF 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.
Product page: Vessix V2 Renal Denervation System…