Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced the first commercial uses of Recor’s Paradise™ Ultrasound Renal Denervation (uRDN) system for the treatment of hypertension, the first FDA approved renal denervation therapy in the United States. The first commercial procedures took place at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City by Drs. Ajay J. Kirtane and Sahil A. Parikh; at the Smidt Heart Institute at Cedars-Sinai in Los Angeles by Drs. Suhail Dohad and Raj Makkar; at Gates Vascular Institute in Buffalo, NY by Dr. Vijay Iyer; and Cleveland Clinic by Dr. Aravinda Nanjundappa.
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.
“It is truly remarkable that patients with difficult-to-control hypertension who are in need of other treatments beyond lifestyle modification and medications now have another option. I just want to thank all of the collaborators and the many patients who committed along the years to the careful study of this technology, allowing this to come to fruition,” said Dr. Ajay Kirtane, professor of medicine and Director of the Columbia Interventional Cardiovascular Care program at Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital.
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.
“A new non-pharmacologic approach to lowering blood pressure in patients whose hypertension has been difficult to control with medications is a welcome addition to the current treatment options available to patients,” said Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence in the Smidt Heart Institute at Cedars-Sinai.
“Catheter-based interventional strategies like that of the Paradise Ultrasound Renal Denervation 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.”
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.
“This new renal denervation technology for a high-risk patient population – individuals with difficult to control hypertension – has been long awaited. We look forward to offering this procedure now to those that will likely derive benefit,” said Aravinda Nanjundappa, M.B.B.S, M.D., Interventional cardiologist at Cleveland Clinic.
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