First FDA Approval of Renal Denervation System to Treat Hypertension Announced by Recor Medical and Otsuka Medical Devices

November 8, 2023 — Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. has announced that the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise Ultrasound Renal Denervation (RDN) system for the treatment of hypertension. Approval of the Paradise Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the United States, according to a written statement detailing the FDA clearance.

The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure, reported the company. The system was described as “a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.” It further reports that the Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.

Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poor quality of life, and higher costs to health systems. The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan, noted the company’s Nov. 8 news release detailing the clearance.

Approval of the Paradise system follows Recor’s positive FDA Advisory Committee Panel in August 2023. Earlier this year, results from Recor’s US pivotal study, the RADIANCE II Randomized Clinical Trial, were published in the Journal of the American Medical Association (JAMA). In the study, the Paradise Ultrasound RDN system met both the primary safety and effectiveness endpoints without any major adverse events.

“Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies,” said Lara Barghout, President and CEO of Recor Medical. She further stated, “We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”

Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009. The RADIANCE global program studied the Paradise system in three independently powered, sham-controlled, randomized clinical trials in over 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild-moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following ultrasound RDN treatment.

Naomi Fisher, MD, Associate Professor of Medicine, Harvard Medical School, and Director of Hypertension Service and Hypertension Innovation, Division of Endocrinology, Diabetes and Hypertension at Brigham and Women’s Hospital, who was the site principal investigator, offered the following in the written statement:

“Despite the longstanding availability of dozens of affordable anti-hypertensive medications, blood pressure control rates in the United States are alarmingly low and falling. Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension. uRDN has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure.”

“Approval of the Paradise Ultrasound RDN system marks an important milestone for the company and provides a new adjunctive treatment option for hypertension which remains inadequately controlled despite conventional therapies,” said Noriko Tojo, President and Representative Director of Otsuka Medical Devices and Executive Director of Otsuka Holdings Co., Ltd.

Headquarterd in Palo Alto, CA, Recor Medical, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. Recor has pioneered the use of the Paradise Ultrasound Renal Denervation system for the treatment of hypertension. The Paradise system is an investigational device in Japan, is FDA approved in the United States, and bears the CE mark.  Recor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension. In addition, Recor has begun the Global Paradise System (“GPS”) Registry in the EU, with plans to expand globally.

Otsuka Medical Devices focuses on the global development and commercialization of medical care products including endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd., a global healthcare company listed on the Tokyo Stock Exchange.

More information: www.recormedical.com