First Renal Denervation Case at GVI; One of Four in the U.S.

Released: Tuesday, November 14, 2023 10:00 AM

First Renal Denervation Case at GVI; One of Four in the U.S.

The Structural Heart Team atGates Vascular Institute, a world-renowned center of excellence for comprehensive neurological, vascular and cardiac services, was one of four teams in the U.S. to successfully complete the first commercial uses of Recor's Paradise^® Ultrasound Renal Denervation (uRDN) System, the first FDA approved renal denervation therapy in the United States, on a 43-year-old Western New York man for the treatment of their uncontrolled hypertension.

The first commercial procedures took place at Gates Vascular Institute in Buffalo, NY; New York-Presbyterian/Columbia University Irving Medical Center in New York, NY; Smidt Heart Institute at Cedars-Sinai in Los Angeles, CA; and Cleveland Clinic in Cleveland, OH

The Paradise system received U.S. Food and Drug Administration (FDA) approval on Nov. 7 as a first-of-its-kind ultrasound-based renal denervation (RDN) technology designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries. Paradise uRDN delivers two to three doses of 360-degree ultrasound energy - lasting seven seconds each - through the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon during the procedure to help cool and protect the inner layers of the renal artery.

"Catheter-based interventional strategies like that of the Paradise system have shown promising results in providing better blood pressure management for eligible patients with resistant hypertension," said Dr. Vijay Iyer, MD, PhD, Director of the Structural Heart Program at Kaleida Health, an interventional cardiologist with Great Lakes Cardiovascular and Chief of the Division of Cardiology at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo. "It is humbling to be part of this breakthrough technology because of the implications and huge potential it has to transform treatments for the entire spectrum of cardiovascular disease for a diverse set of patients in our region and beyond."

Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poorer quality of life, and higher costs to health systems. About one-third of the patients treated for hypertension remain uncontrolled despite lifestyle changes and taking more than three medications. The Paradise uRDN system is now available as an adjunct treatment option for patients who have been unable to achieve blood pressure goals with standard lifestyle changes and oral medications.

The Paradise uRDN system was tested through Recor's RADIANCE Global Program of three rigorous prospectively powered and sham-controlled randomized controlled clinical trials: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-to-moderate hypertension. Each trial successfully met its prespecified primary efficacy endpoint, showing statistically significant and clinically meaningful blood pressure reductions compared to a sham arm and favorable safety profiles.