Renal denervation for control of drug resistant hypertension may soon be a common procedure thanks to a number of companies developing the technology. Having covered Medtronic’s Symplicity and ReCor’s PARADISE, we learn of the V2 system from Vessix Vascular, a company out of Laguna Hills, California. The technology behind the V2 seems to be a hybrid of the competing devices, featuring a balloon catheter like the PARADISE, but like the Symplicity delivering RF energy instead of ultrasound to denervate sympathetic nerves in the renal artery walls.
Vessix just announced that the V2 system is now undergoing testing in an international multi-center clinical trial, and that initial patients with dangerously drug resistant high blood pressure are now being treated.
From the announcement:
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.