Insurance Coverage Initiated for Otsuka Medical’s Paradise Ultrasound Renal Denervation System

Otsuka Medical Devices Co. Ltd. (Otsuka Medical Devices) and Otsuka Pharmaceutical Co. Ltd. (Otsuka Pharmaceutical) said the Paradise Ultrasound Renal Denervation (uRDN) system is now covered by Japan’s National Health Insurance system.

The Paradise uRDN system was developed by Recor Medical Inc., a U.S.-based Otsuka Medical Devices subsidiary. The 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 treatment is designed to lower blood pressure by reducing the overactivity of the sympathetic nerves surrounding the renal arteries.

“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,” stated Kazuomi Kario, president of the Japanese Society of Hypertension and professor of Cardiovascular Medicine at Jichi Medical University. “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.”

With this insurance coverage, Paradise uRDN system becomes available as a new treatment option for resistant hypertension. Under a co-promotion framework, Otsuka Medical Devices and Otsuka Pharmaceutical will leverage Otsuka Pharmaceutical’s expertise in the cardiovascular and renal fields to supply appropriate treatment options suited to patient conditions. The system will be prescribed by physicians to patients as defined in the guidelines for the proper use of renal denervation systems.

“I am delighted that we can provide a new option to address the medical challenge of resistant hypertension by leveraging the know-how cultivated through the Otsuka group’s pharmaceutical business,” commented Makoto Inoue, president/representative director, and CEO of Otsuka Holdings Co. Ltd., and president/representative director of Otsuka Pharmaceutical. “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 U.S. 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/representative director of Otsuka Medical Devices.

* In the U.S, Paradise uRDN system received U.S. Food and Drug Administration approval in November 2023 as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.