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Otsuka Receives Japanese Approval for Paradise Ultrasound System to Treat Resistant Hypertension
Published: August 25, 2025
Article Section: Medical Devices, Cardiology
Backstory: Resistant hypertension, a condition affecting millions globally, poses a significant challenge to healthcare systems. The Paradise ultrasound renal denervation system represents a perhaps groundbreaking non-pharmacological approach to managing this difficult-to-treat form of high blood pressure, offering hope to patients who haven’t responded to conventional therapies.
otsuka Medical Devices Co., Ltd. announced today the receipt of manufacturing and marketing approval in Japan for the Paradise ultrasound renal denervation (uRDN) system. this innovative system is designed to treat resistant hypertension – high blood pressure that remains uncontrolled despite the use of three or more different medications, including a diuretic.
The Paradise uRDN system was developed by Recor Medical, Inc., a U.S.-based subsidiary of Otsuka Medical Devices. the approval in Japan is based on compelling data from the RADIANCE-HTN TRIO study, a rigorous randomized, sham-controlled clinical trial conducted across the United States and Europe.
The RADIANCE-HTN TRIO study enrolled patients already receiving a standardized triple antihypertensive therapy regimen.Results demonstrated a statistically significant and clinically meaningful reduction in daytime ambulatory systolic blood pressure at two months post-treatment with the Paradise uRDN system. Importantly, the system exhibited a consistently favorable safety profile throughout the duration of the study.
Otsuka Medical Devices confirmed that a postmarket surveillance study will be conducted in Japan, adhering to all local regulatory requirements. This ongoing monitoring will provide further insights into the long-term safety and efficacy of the Paradise system within the Japanese population.
The paradise uRDN system has already secured regulatory approvals in key markets, including the United states (FDA approval) and Europe (CE Mark approval). To ensure comprehensive and long-term data collection, the GPS postmarket registry is actively enrolling patients in the European Union, United Kingdom, and United States, with plans for expansion to a global scale.
“This approval marks a significant milestone in our commitment to providing innovative solutions for patients with resistant hypertension,” stated a representative from Otsuka Medical Devices.
“We believe the Paradise system has the potential to transform the treatment landscape for this challenging condition.”
Renal denervation, the underlying principle of the Paradise system, involves using ultrasound energy to disrupt the nerves surrounding the renal arteries. This disruption helps to regulate blood pressure by reducing sympathetic nervous system activity. The Paradise system’s unique ultrasound-based approach aims to offer a precise and targeted treatment option.
Understanding Resistant Hypertension: Trends and Insights
Resistant hypertension is a growing global health concern, frequently enough linked to factors like aging populations, increasing rates of obesity, and lifestyle factors. Current estimates suggest that 10-30% of hypertensive patients experience resistance to conventional therapies. The progress of novel treatment modalities,such as renal denervation,is crucial to address this unmet medical need. Future research will likely focus on identifying ideal patient populations for uRDN and optimizing treatment protocols to maximize efficacy and long-term benefits.
