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

Key Takeaways

• Insurance coverage enables reimbursement for Paradise uRDN in Japan
• System targets resistant hypertension unresponsive to three drugs
• First ultrasound renal denervation therapy available nationally
• Co‑promotion leverages Otsuka Pharmaceutical’s cardiovascular expertise
• FDA‑approved device now accessible to Japanese patients

Summary

Otsuka Medical Devices and Otsuka Pharmaceutical announced that Japan’s National Health Insurance will cover the Paradise™ Ultrasound Renal Denervation (uRDN) system starting March 1, with commercial sales beginning March 2. The device, developed by Recor Medical, targets resistant‑hypertension patients who remain uncontrolled despite three antihypertensive drugs. This marks the first nationwide introduction of ultrasound‑based renal denervation in Japan. Otsuka will co‑promote the system alongside its cardiovascular drug portfolio to streamline patient access.

Pulse Analysis

Resistant hypertension affects roughly 10‑15 % of Japanese adults, remaining above target despite three or more antihypertensive agents. Persistent elevation drives strokes, heart failure, and renal decline, creating a costly burden for the national health system. Over the past decade, catheter‑based renal denervation has emerged as a non‑pharmacologic option that interrupts sympathetic signaling along the renal arteries. Early trials demonstrated modest but consistent blood‑pressure reductions, prompting regulators worldwide to reconsider coverage for patients who have exhausted medication regimens.

The Paradise™ ultrasound renal denervation (uRDN) system, developed by Recor Medical, uses high‑frequency sound waves to achieve circumferential ablation without thermal injury. Clinical data submitted to the FDA showed an average systolic drop of 8‑10 mmHg in patients on triple therapy, leading to its 2023 approval as an adjunctive treatment. Japan’s National Health Insurance now reimburses the device as of March 1, and Otsuka Medical Devices began commercial sales on March 2, marking the first nationwide availability of ultrasound‑based renal denervation. A co‑promotion agreement with Otsuka Pharmaceutical will pair the device with the group’s cardiovascular drug portfolio.

The reimbursement decision unlocks a sizable market, estimated at several thousand eligible patients annually, and positions Otsuka as a pioneer in Japan’s interventional hypertension space. By integrating the uRDN system with its existing drug offerings, Otsuka can deliver a bundled therapeutic pathway that may improve adherence and outcomes. Health‑economics analyses suggest that even modest blood‑pressure reductions can lower cardiovascular event rates, offering long‑term cost savings for insurers. As guidelines from Japanese societies evolve, broader adoption of renal denervation could reshape standard care for resistant hypertension across Asia.