Otsuka Medical Devices Announces Japan Approval of Paradise uRDN System

August 25, 2025—Otsuka Medical Devices Co., Ltd. announced that the Paradise ultrasound renal denervation (uRDN) system has received manufacturing and marketing approval in Japan for the treatment of resistant hypertension. The Paradise uRDN system was developed by Recor Medical, Inc., a United States–based subsidiary of Otsuka Medical Devices.

According to Otsuka Medical Devices, approval in Japan was based on the results of the RADIANCE-HTN TRIO study conducted in the United States and Europe. The randomized, sham-controlled clinical trial evaluated the Paradise uRDN system in patients with resistant hypertension on a standardized triple antihypertensive therapy, including a diuretic.

The study met its prescribed primary efficacy endpoint, demonstrating a significant reduction in daytime ambulatory systolic blood pressure at 2 months postrandomization. A favorable safety profile was consistently observed throughout the study, reported the company.

A postmarket surveillance study will be conducted in Japan in accordance with local regulatory requirements, stated Otsuka Medical Devices.

The company noted that the Paradise uRDN system has received FDA approval and CE Mark approval. To facilitate the comprehensive and long-term collection of postmarket data, the GPS postmarket registry has been initiated in the European Union, United Kingdom, and United States, with plans for global expansion.