First Patients Treated in Hypertension Clinical Study Using the Vessix Vascular Balloon Catheter Renal Denervation System
LAGUNA HILLS, Calif., Feb. 23, 2012 /PRNewswire/ -- Vessix Vascular, Inc., a developer of novel percutaneous radiofrequency (RF) balloon catheter technology, announced today initial patient treatments in the international multi-center REDUCE-HTN renal denervation clinical study for uncontrolled hypertension.
REDUCE-HTN is a non-randomized, prospective, single cohort, 64-patient clinical study designed to validate the clinical performance of the Vessix V2 Renal Denervation System™ for medication-resistant hypertensive patients. Renal denervation is a new percutaneous catheter-based procedure that disrupts renal sympathetic nerves whose hyperactivity leads to abnormally high blood pressure.
The renal denervation procedures employing the Vessix balloon catheter were performed at Paracelsus Medical University in Salzburg, Austria by Prof. Uta Hoppe, a world-class interventional cardiologist with extensive renal denervation experience in Germany and Austria.
The first patient treated was 39 years old with pre-treatment blood pressure readings of 174/114 despite taking four anti-hypertensive medications. The second patient was 44 years old with a blood pressure of 168/106 despite taking six anti-hypertensive medications.
"We found the catheter easy to use and quite efficient in terms of therapy time. Moreover, the patient required modest amounts of intravenous anxiolytics and narcotics since the therapy was delivered in a matter of seconds," said Prof. Hoppe following the procedure. "We will, of course, closely monitor the patients and are optimistic that the Vessix approach will produce a measurable reduction in blood pressure."
By design, all patients enrolled in the study have a baseline systolic blood pressure greater than 160 mm Hg despite being treated by at least three anti-hypertensive drugs. The 10-center REDUCE-HTN study will enroll patients at leading medical centers in Austria, Belgium, Germany, Switzerland, France, Netherlands and Australia. The study, which calls for patients to be followed for 24 months, will capture post-treatment office-based and ambulatory blood pressure measurements at various time points in accordance with internationally recognized guidelines. In addition to assessing the patient's clinical condition, the renal arteries of treated patients will be imaged at various time points post-treatment to confirm safety of the procedure.
Raymond W. Cohen, Vessix Vascular's CEO, said, "The initiation of the REDUCE-HTN study begins a new chapter for Vessix. Seeing the first patients treated is satisfying for our employees, physician advisors and collaborators who have supported the V2 product development efforts and extensive pre-clinical work over the past few years. Our therapy is a result of diligently leveraging eight years of engineering experience in RF balloon catheter design and bipolar RF generator technology to create an elegant product that we believe represents a potential game-changer in the emerging field of renal denervation. We look forward to working with the first class clinical investigators and institutions participating in the study and sharing the clinical results in the coming months."
About the Vessix V2 Renal Denervation System
The V2 System for the treatment of medication-resistant hypertension is an over-the-wire balloon catheter with an array of RF electrodes 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 energy to the target nerves. Consequently, the V2 is significantly faster – by an order of magnitude – than the only renal denervation system currently marketed.
Rapid RF treatment time greatly increases the efficiency of the denervation procedure and promises 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.
About Vessix Vascular, Inc.
Founded in 2003, Vessix is a privately held pre-revenue stage company developing novel radiofrequency balloon catheter technology. The Company is backed by world-class European and U.S. venture firms including NeoMed Management AS, Edmond de Rothschild Investment Partners and OrbiMed Advisors LLC. For more information on Vessix Vascular, please visit the Company's website at www.vessixvascular.com or contact Matt Clawson at Allen & Caron Inc at 949-474-4300 or via email at [email protected].