Otsuka Medical Devices/Otsuka Pharmaceutical: Paradise Ultrasound Renal Denervation System for the Treatment of Resistant Hypertension, Now Covered by Insurance and Commercially Available in Japan

TOKYO–(BUSINESS WIRE)–Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices) and Otsuka Pharmaceutical Co., Ltd. (Otsuka Pharmaceutical) announce that the Paradise Ultrasound Renal Denervation (uRDN) system is covered by National Health Insurance system in Japan, effective March 1. 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, Inc. (Recor Medical), a U.S.-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.

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 established 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.

Kazuomi Kario, President of the Japanese Society of Hypertension and Professor of Cardiovascular Medicine at Jichi Medical University, 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 Co., Ltd., 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 know-how 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 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 and Representative Director of Otsuka Medical Devices.

Guided by the corporate philosophy of Otsuka-people creating new products for better health worldwide, Otsuka Medical Devices and Otsuka Pharmaceutical will continue to make every effort to deliver new value to address unmet medical needs.

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

About Otsuka Medical Devices
https://www.omd.otsuka.com/en/

About Recor Medical
https://www.recormedical.com/

About Otsuka Pharmaceutical
https://www.otsuka.co.jp/en/

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