Otsuka Medical Devices Secures First Japanese Approval for Paradise™ Ultrasound Renal Denervation System to Treat Resistant Hypertension
Otsuka Medical Devices Co., Ltd. has achieved a significant regulatory milestone with the announcement that its Paradise™ Ultrasound Renal Denervation (uRDN) system has received manufacturing and marketing approval in Japan for the treatment of resistant hypertension. The authorization, granted on August 25, makes this the first approval in Japan for a medical device specifically indicated to treat resistant hypertension, marking a landmark moment in the country’s cardiovascular care landscape.
The Paradise uRDN system was originally developed by Recor Medical, Inc., a U.S.-based subsidiary of Otsuka Medical Devices. With this approval, Japan joins the U.S. and Europe in recognizing the technology as a clinically validated and innovative treatment for patients whose blood pressure remains uncontrolled despite standard drug therapies.
Clinical Evidence Underpinning Approval
The regulatory decision in Japan is primarily supported by clinical evidence from the RADIANCE-HTN TRIO study, a pivotal international trial conducted across the U.S. and Europe. This was a randomized, sham-controlled trial that specifically enrolled patients with resistant hypertension — those whose blood pressure remains elevated despite being on a standardized triple antihypertensive regimen, including a diuretic.
Results from the study demonstrated that the Paradise uRDN system met its primary efficacy endpoint, showing a statistically significant reduction in daytime ambulatory systolic blood pressure (ASBP) two months after randomization. Importantly, the trial also confirmed the favorable safety profile of the technology, with no major adverse effects linked to the procedure, reinforcing its viability as a safe interventional option for high-risk patients.
How the Paradise uRDN System Works
The Paradise system represents a next-generation, minimally invasive therapy that targets the root physiological mechanisms contributing to hypertension. Rather than simply managing symptoms through medication, the technology directly addresses overactivity in the sympathetic nervous system, which plays a central role in driving persistently high blood pressure.
The system works by delivering two to three short bursts of 360-degree ultrasound energy, each lasting about seven seconds, to the renal arteries. These arteries, located in the kidneys, are surrounded by sympathetic nerves that contribute to blood pressure regulation. By selectively ablating (or disrupting) these nerves, the therapy effectively reduces their overactivity, which in turn helps lower blood pressure.
One of the notable features of the Paradise uRDN catheter is its proprietary HydroCooling™ system. During the procedure, sterile water circulates through the balloon catheter, cooling the arterial wall and thereby protecting it from thermal damage while the ultrasound energy denervates the surrounding nerves. This innovation enhances both the safety and precision of the therapy, allowing effective nerve disruption while minimizing risks to vascular structures.
Voices from Japan’s Leading Medical Societies
The approval has drawn strong endorsements from several of Japan’s most influential cardiovascular medical societies, reflecting the significance of this therapeutic advancement.
- Professor Kazuomi Kario, President of the Japanese Society of Hypertension and Professor of Cardiovascular Medicine at Jichi Medical University, emphasized the seriousness of resistant hypertension:
“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.” - Professor Yoshio Kobayashi, President of the Japanese Circulation Society and Professor of Cardiovascular Medicine at Chiba University Graduate School of Medicine, highlighted the broader public health impact of the therapy:
“Hypertension is a leading cause of cardiovascular diseases, which are among the top three causes of death in Japan. We are hopeful that the Paradise uRDN system will expand treatment possibilities and contribute to the prevention of cardiovascular events.” - Professor Ken Kozuma, President of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) and Chairman of Internal Medicine and Cardiology at Teikyo University Hospital, underscored the importance of minimally invasive cardiovascular therapies:
“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.”
Industry Perspective and Global Momentum
Otsuka Medical Devices’ leadership also expressed optimism about the device’s role in advancing patient care in Japan. Noriko Tojo, President and Representative Director of Otsuka Medical Devices, noted the strong reception of the Paradise system in global markets:
“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 innovative 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.”
The Paradise system already holds U.S. FDA approval (2023) and the CE mark in Europe, which certifies compliance with European Union safety and performance standards. These approvals and launches highlight the global confidence in the system’s ability to address an area of persistent unmet medical need.
Post-Marketing Studies and Global Registries
With regulatory approval in Japan, Otsuka will move forward with a post-marketing surveillance (PMS) study to ensure continued safety and efficacy monitoring in accordance with local requirements. Such studies are critical for building long-term data on patient outcomes, particularly in diverse populations.
Internationally, the company has also launched the Global Paradise System (GPS) post-market registry across the EU, UK, and U.S. The registry is designed to collect comprehensive and long-term real-world evidence on the safety, performance, and patient impact of the system. Otsuka has indicated plans to expand this registry globally, creating one of the most extensive data sets available for renal denervation technology.
Addressing a Major Unmet Need in Hypertension
Hypertension remains one of the leading global health challenges, affecting more than 1 billion people worldwide. While many patients achieve control with lifestyle interventions and medications, a significant subset — estimated at 10–15% — suffer from resistant hypertension, meaning their blood pressure remains elevated despite being on at least three antihypertensive drugs, including a diuretic.
This group faces a particularly high risk of complications such as stroke, heart attack, heart failure, kidney disease, and premature death. Traditional therapeutic approaches often provide limited benefit, leaving both patients and physicians frustrated by the lack of effective alternatives.
By directly targeting the sympathetic nervous system through renal denervation, the Paradise uRDN system introduces a fundamentally new treatment paradigm. Its minimally invasive nature and proven clinical efficacy offer hope of improved outcomes for patients whose options were previously restricted to medication adjustments and lifestyle changes that often failed to yield sufficient results.
