TOKYO, Japan – March 1, 2026
Otsuka Medical Devices Co., Ltd. and Otsuka Pharmaceutical Co., Ltd. announced that the Paradise™ Ultrasound Renal Denervation (uRDN) System is now covered under Japan’s National Health Insurance (NHI) system, effective March 1, with commercial sales commencing March 2. The milestone marks the first introduction of ultrasound renal denervation therapy in Japan for the treatment of resistant hypertension, expanding access to a novel device-based intervention for patients whose blood pressure remains uncontrolled despite multiple medications.
The Paradise uRDN system, developed by Recor Medical, Inc., a U.S.-based subsidiary of Otsuka Medical Devices, is indicated for patients with resistant hypertension who continue to have elevated blood pressure despite treatment with at least three antihypertensive drugs of different classes, including a diuretic. The system works by delivering targeted ultrasound energy to reduce overactivity of sympathetic nerves surrounding the renal arteries, thereby helping lower blood pressure.
A New Interventional Option for Resistant Hypertension
Resistant hypertension is associated with a significantly elevated risk of stroke, cardiovascular disease, and renal failure, making effective management critical. Traditional pharmacologic approaches can be insufficient for certain patients, underscoring the need for alternative strategies. The Paradise uRDN system provides a minimally invasive, catheter-based procedure designed to disrupt renal sympathetic nerve signaling, a known contributor to persistent hypertension.
In the United States, the system received approval from the U.S. Food and Drug Administration (FDA) in November 2023 as an adjunctive treatment when lifestyle modifications and medications fail to achieve adequate blood pressure control. The technology is also CE marked and approved in other international markets. Clinical studies, including randomized, sham-controlled trials, have demonstrated positive outcomes in both mild-to-moderate and resistant hypertension populations, supporting its global regulatory expansion.
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Co-Promotion Strategy and Clinical Governance
Following the initiation of insurance reimbursement, Otsuka Medical Devices has begun sales activities and will conduct co-promotion efforts with Otsuka Pharmaceutical, leveraging the latter’s established expertise in cardiovascular and renal disease management. The companies emphasized that the system will be prescribed according to national guidelines and facility requirements established by Japanese medical societies, including the Japanese Society of Hypertension, the Japanese Association of Cardiovascular Intervention and Therapeutics, and the Japanese Circulation Society.
Clinical oversight will focus on ensuring appropriate patient selection and procedural safety, reflecting a structured framework for introducing renal denervation into routine clinical practice. By aligning device deployment with established hypertension treatment pathways, Otsuka aims to integrate renal denervation as a complementary therapy alongside existing pharmacologic regimens.
Advancing Cardiovascular Innovation in Japan
The launch represents a strategic expansion of Otsuka’s cardiovascular portfolio, combining pharmaceutical expertise with advanced interventional medical technologies. Otsuka Medical Devices continues to focus on developing and commercializing therapies that address unmet needs beyond conventional drug treatment, particularly in chronic diseases where device-based approaches may provide additive benefits.
With Japan’s National Health Insurance coverage now in place, the Paradise uRDN system becomes accessible to a broader patient population, potentially transforming management strategies for resistant hypertension. The collaboration between device and pharmaceutical divisions within the Otsuka group reflects a growing convergence of interventional MedTech innovation and cardiovascular disease management, reinforcing the company’s commitment to advancing total healthcare solutions.
As global hypertension prevalence continues to rise, the integration of renal denervation into mainstream treatment paradigms may play a significant role in reducing long-term cardiovascular risk and improving patient outcomes in high-risk populations.
Source: Otsuka press release
