Otsuka Medical Devices Co., Ltd. has received manufacturing and marketing approval in Japan for the Paradise™ Ultrasound Renal Denervation (uRDN) system, the nation’s first medical device approved for treating resistant hypertension.
Developed by Recor Medical, Inc., a U.S.-based subsidiary of Otsuka Medical Devices, the system’s approval is supported by results from the RADIANCE-HTN TRIO trial conducted in the U.S. and Europe. This randomized, sham-controlled study showed that the Paradise uRDN system significantly lowered daytime ambulatory systolic blood pressure in patients with resistant hypertension, while maintaining a favorable safety profile.
The device works by delivering 360-degree ultrasound energy to the renal arteries, disrupting overactive sympathetic nerves that drive hypertension. Its unique HydroCooling™ technology circulates sterile water during treatment to protect the arterial wall.
Key cardiovascular societies in Japan — the Japanese Society of Hypertension, the Japanese Circulation Society, and the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) — welcomed the approval, highlighting its potential to reduce cardiovascular risk and expand treatment options for high-risk patients.
The Paradise uRDN system, already FDA-approved in the U.S. (2023) and CE-marked in Europe, will also undergo a post-marketing surveillance (PMS) study in Japan to ensure long-term safety and efficacy. Otsuka aims to continue advancing innovative endovascular treatments to address unmet needs in cardiovascular care.