Japanese Regulators Approve Otsuka Medical’s Renal Denervation System

Otsuka Medical Devices Co. Ltd.’s (Otsuka Medical Devices) Paradise Ultrasound Renal Denervation (uRDN) system has received approval in Japan for treating resistant hypertension. The approval is the country’s first for a medical device indicated for the disease.

“Hypertension is a leading cause of cardiovascular diseases, which are among the top three causes of death in Japan. We are hopeful the Paradise uRDN system will expand treatment possibilities and contribute to the prevention of cardiovascular events,” stated Yoshio Kobayashi, president of the Japanese Circulation Society and professor of Cardiovascular Medicine at Chiba University Graduate School of Medicine.

The Paradise uRDN system was developed by Recor Medical Inc., a U.S.-based subsidiary of Otsuka Medical Devices.

This approval is based on 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 (ASBP) at two months post-randomization. A favorable safety profile was consistently observed throughout the study.

“Resistant hypertension is a particularly high-risk form of high blood pressure, and it is difficult to control despite medication. The Paradise uRDN system offers a new treatment option for these patients. In a collaborative initiative involving three leading academic societies—the Japanese Society of Hypertension, the Japanese Circulation Society, and the Japanese Association of Cardiovascular Intervention and Therapeutics—we are committed to raising awareness about this disease and its treatment options to ensure appropriate care is accessible to patients in need,” commented Kazuomi Kario, president of the Japanese Society of Hypertension and professor of Cardiovascular Medicine at Jichi Medical University.

The Paradise uRDN system is a novel ultrasound-based renal denervation technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The 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 arterial wall.

“Cardiovascular catheter-based interventions are minimally invasive and have become widely adopted as a central component of proactive cardiovascular care. With this approval, we are pleased to see that an innovative catheter-based treatment has been recognized as a new treatment option for resistant hypertension—a major contributor to cardiovascular disease—offering patients a less invasive therapeutic option,” said Ken Kozuma, president of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) and professor/chairman of Internal Medicine and Cardiology at Teikyo University Hospital.

The Paradise uRDN system received U.S. Food and Drug Administration approval in 2023 and bears a CE mark. To facilitate the comprehensive and long-term collection of post-marketing data, the Global Paradise System (GPS) post-market registry has been initiated in the European Union, U.K., and United States, with plans for global expansion. In Japan, a post-marketing surveillance (PMS) study will be conducted in accordance with local regulatory requirements.

“The Paradise uRDN system has been well received by both patients and physicians in the U.S., where it received FDA approval and was launched in November 2023. We are delighted to now offer this treatment option to patients in Japan and contribute to their health and well-being. We remain committed to advancing medical care and supporting patients through innovative solutions,” Otsuka Medical Devices President/Representative Director Noriko Tojo concluded.

Otsuka Medical Devices addresses unmet medical needs through the development and commercialization of therapies, particularly in endovascular treatment.