Recor Medical, Inc., and its parent company, Otsuka Medical Devices Co., Ltd., have announced the first commercial uses of the Paradise Ultrasound Renal Denervation (uRDN) system in the United States. This system, recently approved by the FDA, marks a significant advancement in hypertension treatment.

First-of-its-Kind Technology for Hypertension

• The Paradise system is a novel ultrasound-based renal denervation technology, receiving FDA approval on Nov. 7, 2023. It’s designed to lower blood pressure by denervating overactive sympathetic nerves surrounding the renal arteries.
• The system delivers ultrasound energy through the renal arteries to the surrounding nerves, featuring the unique HydroCooling™ system that cools and protects the renal artery during the procedure.

Commercial Implementation and Impact

• The first commercial procedures were conducted at prominent medical centers across the U.S., including NewYork-Presbyterian/Columbia University Irving Medical Center, Smidt Heart Institute at Cedars-Sinai, Gates Vascular Institute, and Cleveland Clinic.
• Specialists in cardiology have acknowledged the system as a breakthrough in hypertension management, especially for patients with resistant hypertension who have not responded to standard treatments.

Clinical Trials and Patient Impact

• The Paradise uRDN system was rigorously tested through Recor’s RADIANCE Global Program, including three randomized controlled clinical trials. These trials showed significant blood pressure reductions and favorable safety profiles.
• This technology offers a new non-pharmacologic approach to lowering blood pressure in patients with difficult-to-control hypertension.

Expert Opinions on the New Treatment

Medical professionals have praised the introduction of the Paradise system, noting its potential to transform treatments for cardiovascular disease and improve the quality of life for many patients. The system is now an adjunct treatment option for patients with hypertension who have not achieved their blood pressure goals with standard lifestyle changes and oral medications.

  Hypertension, Otsuka Medical Devices, Paradise Ultrasound Renal Denervation, Recor Medical, uRDN system