Otsuka's Paradise Ultrasound Renal Denervation System Gains Insurance Coverage in Japan for Resistant Hypertension
核心洞察
Otsuka Medical Devices (搜索) and Otsuka Pharmaceutical (搜索) launched the Paradise Ultrasound Renal Denervation system (搜索) in Japan with National Health Insurance coverage effective March 1, 2026.
The system represents Japan's first ultrasound renal denervation treatment, targeting resistant hypertension (搜索) patients whose blood pressure remains elevated despite three different antihypertensive medications (搜索) including a diuretic (搜索).
The treatment works by reducing overactivity of sympathetic nerves (搜索) surrounding renal arteries (搜索), offering a novel approach for patients at extremely high risk of serious cardiovascular complications.
Otsuka Medical Devices (搜索) and Otsuka Pharmaceutical (搜索) have launched the Paradise™ Ultrasound Renal Denervation (uRDN) system in Japan with National Health Insurance coverage, marking the first introduction of ultrasound renal denervation treatment in the country. The system became available under insurance coverage on March 1, 2026, with sales commencing March 2 under a co-promotion framework between the two companies.
Novel Treatment for Resistant Hypertension
The Paradise uRDN system, developed by Recor Medical (搜索), Inc., a U.S.-based subsidiary of Otsuka Medical Devices (搜索), is specifically indicated for resistant hypertension (搜索) patients whose blood pressure remains above target despite the use of three antihypertensive medications (搜索) of different classes, including a diuretic (搜索). The treatment represents a significant advancement in addressing this challenging patient population.
The system operates by reducing overactivity of the sympathetic nerves (搜索) surrounding the renal arteries (搜索), thereby lowering blood pressure through this novel mechanism of action. This approach provides a new therapeutic option for patients who have exhausted conventional pharmaceutical interventions.
Clinical Significance and Expert Commentary
Kazuomi Kario, President of the Japanese Society of Hypertension (搜索) and Professor of Cardiovascular Medicine at Jichi Medical University, emphasized the clinical importance of this development: "Resistant hypertension (搜索) carries an extremely high risk of leading to serious complications, such as cerebrovascular and cardiovascular diseases (搜索) and renal failure (搜索). Being able to provide appropriate treatment opportunities to patients in need through this insurance coverage marks a significant step forward."
The Japanese Society of Hypertension (搜索), the Japanese Association of Cardiovascular Intervention and Therapeutics (搜索), and the Japanese Circulation Society (搜索) have collaborated to establish comprehensive guidelines for the proper use of renal denervation systems. These guidelines outline facility requirements and patient eligibility criteria to ensure safe and appropriate treatment delivery.
Regulatory Background and Global Approval
The Paradise uRDN system received approval from the U.S. Food and Drug Administration (FDA) in November 2023 as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient's blood pressure. The system is also CE marked and approved for sale in markets where the CE mark is accepted, per approved indications for use.
Recor Medical (搜索) has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise uRDN system in patients with mild-to-moderate and resistant hypertension (搜索). The company has initiated the Global Paradise System (GPS) Registry in the European Union and the UK, and has begun the US GPS post-approval study in the United States.
Strategic Implementation
Under the co-promotion framework, Otsuka Medical Devices (搜索) and Otsuka Pharmaceutical (搜索) will leverage Otsuka Pharmaceutical's established expertise in the cardiovascular and renal fields to supply appropriate treatment options suited to patient conditions. The system will be prescribed by physicians to patients as defined in the guidelines for the proper use of renal denervation systems.
Makoto Inoue, President and Representative Director, CEO of Otsuka Holdings Co., Ltd., and President and Representative Director of Otsuka Pharmaceutical (搜索), stated: "I am delighted that we can provide a new option to address the medical challenge of resistant hypertension (搜索) by leveraging the know-how cultivated through the Otsuka group's pharmaceutical business."
Noriko Tojo, President and Representative Director of Otsuka Medical Devices (搜索), added: "We are extremely pleased that patients in Japan with resistant hypertension (搜索) now have access to this new treatment option under insurance coverage. We have built a framework with Otsuka Pharmaceutical (搜索) to ensure this treatment reliably reaches patients in need, and we will continue to contribute to the health of patients and the advancement of medical care."