The Paradise ultrasound renal denervation (uRDN) system is covered by National Health Insurance system in Japan, effective March 1, Otsuka Medical Devices has announced.
Following the inception of insurance coverage, Otsuka Medical Devices has commenced sales of the system on March 2 and will conduct co-promotion with Otsuka Pharmaceutical.
The Paradise uRDN system was developed by Recor Medical, the US-based subsidiary of Otsuka Medical Devices. This system is indicated for resistant hypertension patients whose blood pressure remains above target despite the use of three antihypertensive medications of different classes, including a diuretic.
Otsuka Medical Devices is introducing ultrasound renal denervation treatment to Japan for the first time. This novel treatment is designed to lower blood pressure by reducing overactivity of the sympathetic nerves surrounding the renal arteries.
Kazuomi Kario, president of the Japanese Society of Hypertension and professor of cardiovascular medicine at Jichi Medical University (Shimotsuke, Japan), commented: “Resistant hypertension carries an extremely high risk of leading to serious complications, such as cerebrovascular and cardiovascular diseases and renal failure. Being able to provide appropriate treatment opportunities to patients in need through this insurance coverage marks a significant step forward. Furthermore, the Japanese Society of Hypertension, the Japanese Association of Cardiovascular Intervention and Therapeutics, and the Japanese Circulation Society will work together to ensure that proper and safe treatment is delivered based on the facility requirements and patient eligibility criteria outlined in the guidelines for the proper use of renal denervation systems, which were formulated by our three societies.”
Makoto Inoue, president and representative director, CEO of Otsuka Holdings, and president and representative director of Otsuka Pharmaceutical stated: “I am delighted that we can provide a new option to address the medical challenge of resistant hypertension by leveraging the knowhow cultivated through the Otsuka group’s pharmaceutical business. Moving forward, we will bring together the collective strength of the Otsuka group to deliver optimal solutions for patients and consumers, as we strive to contribute to the total healthcare of every individual.”
“Paradise uRDN system received approval from the US Food and Drug Administration (FDA) in 2023. We are extremely pleased that patients in Japan with resistant hypertension now have access to this new treatment option under insurance coverage. We have built a framework with Otsuka Pharmaceutical to ensure this treatment reliably reaches patients in need, and we will continue to contribute to the health of patients and the advancement of medical care,” said Noriko Tojo, president and representative director of Otsuka Medical Devices.
