FDA Approves Recor Medical’s Paradise Renal Denervation System for Hypertension Treatment

November 7, 2023—Recor Medical announced it has received United States FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension. A subsidiary of Otsuka Medical Devices Co. Ltd., Recor notes that the Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.

An FDA Advisory Committee Panel reviewed data supporting the Paradise system in August 2023, resulting in a favorable vote. The company’s RADIANCE II clinical trial met its primary safety and efficacy endpoints, and its data were published in the Journal of the American Medical Association. At TCT 2023 in October, Ajay Kirtane, MD, presented positive results from a combined analysis of 6-month follow-up data from the three RADIANCE global clinical studies evaluating the Paradise system. The data demonstrated maintenance of blood pressure reduction compared to sham, with fewer hypertensive treatments. The study results were simultaneously published by Michel Azizi, MD, et al online in Circulation.

Recor says its ultrasound-based Paradise system denervates the sympathetic nerves that surround the renal arteries, the overactivity of which can lead to hypertension. It includes a HydroCooling system that circulates sterile water through the balloon catheter to help protect the renal artery wall, the company notes. The platform gained CE Mark in 2012 and is available in Europe. It is currently an investigational device in Japan, the company notes.

“It is truly remarkable to witness the approval of this technology that has the potential to help patients with difficult-to-control hypertension who are in need of other options beyond lifestyle modification and medications,” said Dr. Kirtane in comments to Cardiac Interventions Today on the approval. “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.” Dr. Kirtane is Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital in New York.

“Despite the longstanding availability of dozens of affordable antihypertensive medications, blood pressure control rates in the United States are alarmingly low and falling,” said Naomi Fisher, MD, in the Recor announcement. Dr. Fisher is a site principal investigator and is 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. “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.”

Noriko Tojo, President and Representative Director of Otsuka Medical Devices and Executive Director of Otsuka Holdings Co., Ltd., added, “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. We are excited for patients and their healthcare professionals to have access to this technology to assist in managing hypertension and improving outcomes.”