TOKYO--(BUSINESS WIRE)--Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announced that the Paradise™ Ultrasound Renal Denervation (uRDN) system has received approval for manufacturing and marketing in Japan for the treatment of resistant hypertension on August 25. This marks the first approval in the country for a medical device indicated for the disease. The Paradise uRDN system was developed by Recor Medical, Inc., a U.S.-based subsidiary of Otsuka Medical Devices.
This approval is based on the results of the RADIANCE-HTN TRIO study conducted in the U.S. 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.
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.
“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.
“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.” stated Yoshio Kobayashi, President of the Japanese Circulation Society and Professor of Cardiovascular Medicine at Chiba University Graduate School of Medicine.
“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.” added Ken Kozuma, President of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT), and Professor and Chairman of Internal Medicine and Cardiology at Teikyo University Hospital.
“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.” said Noriko Tojo, President and Representative Director of Otsuka Medical Devices.
The Paradise uRDN system received U.S. FDA 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 EU, UK, and U.S., with plans for global expansion. In Japan, a post-marketing surveillance (PMS) study will be conducted in accordance with local regulatory requirements.
Otsuka Medical Devices continues to address unmet medical needs through the development and commercialization of innovative therapies, particularly in the field of endovascular treatment.
*CE mark: A mark indicating that a product sold in EU member countries complies with EU standards for safety and other requirements.
Otsuka Medical Devices Co., Ltd.
https://www.omd.otsuka.com/en/
About Recor Medical, Inc.
https://www.recormedical.com/
Contacts
Otsuka Medical Devices Co., Ltd.
https://www.omd.otsuka.com/en/contact/
+81-3-6361-7459
