Recor Medical, Inc. (“Recor”), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today that the Paradise™ Ultrasound Renal Denervation (uRDN) system has received approval for manufacturing and marketing in Japan for the treatment of resistant hypertension. This marks the first approval in the country for a medical device indicated for the disease.
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 aninnovative 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.
“We are pleased that the Paradise uRDN system is the first Renal Denervation device to be approved in Japan, making it the first treatment of its kind available to patients in the country,” commented Lara Barghout, President and CEO of Recor Medical. “Hypertension knows no global boundaries. Expanding access to this innovative therapy is central to our mission, and we are passionate about providing transformative solutions that improve both the health and quality of life for patients around the world.”
“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. The Global Paradise System (GPS) post-market registry has been initiated in the EU and UK, along with the GPS post-approval study in the U.S., with plans for global expansion to support the collection of long-term data. In Japan, a post-marketing surveillance (PMS) study will be conducted in accordance with local regulatory requirements.