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March 2, 2026

Otsuka’s Paradise uRDN System Launched in Japan With National Health Insurance Coverage


KEY TAKEAWAYS

  • Paradise ultrasound renal denervation system is launched in Japan after receiving National Health Insurance coverage.
  • The device received marketing approval in Japan in August 2025, indicated for uncontrolled hypertension that is resistant to treatment with three classes of hypertensive medications.
  • The Japanese hypertension and cardiovascular societies will collaborate to ensure guideline-directed treatment is delivered.

March 2, 2026—Otsuka Medical Devices Co., Ltd. and Otsuka Pharmaceutical Co., Ltd., announced the commercial launch of the Paradise ultrasound renal denervation (uRDN) system. Coverage was approved by the National Health Insurance system in Japan, effective March 1.

The companies advised that the Paradise system is indicated for patients with resistant hypertension whose blood pressure remains above target despite the use of three antihypertensive medications of different classes, including a diuretic. In August 2025, Otsuka Medical Devices announced it received manufacturing and marketing approval in Japan.

Sales of the Paradise uRDN system in Japan commenced on March 2 through a copromotion in which Otsuka Medical Devices will leverage Otsuka Pharmaceutical’s expertise in the cardiovascular and renal fields to supply appropriate treatment options suited to patient conditions, noted the companies.

Kazuomi Kario, MD, President of the Japanese Society of Hypertension and Professor of Cardiovascular Medicine at Jichi Medical University in Tochigi, Japan, commented on the milestone in the companies’ press release.

“Resistant hypertension carries an extremely high risk of leading to serious complications, such as cerebrovascular and cardiovascular diseases and renal failure,” stated Dr. Kario. “Being able to provide appropriate treatment opportunities to patients in need through this insurance coverage marks a significant step forward.”

Dr. Kario continued, “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.”

As noted in the press release, the Paradise uRDN system was developed by Recor Medical, Inc., a United States-based subsidiary of Otsuka Medical Devices. FDA approval of the Paradise uRDN system in the United States was announced in November 2023.

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