LAGUNA HILLS Calif.— 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.”