On 23 February 2012, Vessix Vascular announced initial patient treatments in the international multicentre REDUCE-HTN renal denervation clinical study for uncontrolled hypertension. REDUCE-HTN is a non-randomised, 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 Uta Hoppe.
The first patient treated was 39 years old with pre-treatment blood pressure readings of 174/114mmHg despite taking four anti-hypertensive medications. The second patient was 44 years old with a blood pressure of 168/106mmHg 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 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 160mmHg despite being treated by at least three anti-hypertensive drugs. The 10-centre REDUCE-HTN study will enrol patients at leading medical centres in Austria, Belgium, Germany, Switzerland, France, The 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 radiofrequency balloon catheter design and bipolar radiofrequency 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 radiofrequency electrodes 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 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 radiofrequency 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.