Otsuka Wins Japan’s First OK for Paradise RDN System

Otsuka Medical Devices got approval in Japan for the Paradise Ultrasound Renal Denervation (uRDN) system. This device is the first approved in the country for treating resistant hypertension. Recor Medical, a U.S. branch of Otsuka, created this system. It offers a new, minimally invasive option for patients whose high blood pressure remains high despite multiple medications.

Results from the RADIANCE-HTN TRIO trial in the U.S. and Europe backed the approval. The randomized, sham-controlled study showed a big drop in daytime systolic blood pressure after two months. It also had a good safety profile. The system uses ultrasound energy to disrupt overactive renal sympathetic nerves. This helps lower blood pressure. Its HydroCooling feature helps protect the arterial wall during treatment.

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Resistant hypertension is a key cardiovascular risk factor. Experts from Japan’s top academic societies highlighted that this system could broaden treatment options and lessen health burdens. The Paradise uRDN system is already FDA-approved in the U.S. and CE-marked in Europe. It will have post-marketing surveillance in Japan. This will help check long-term outcomes. This approval highlights a shift toward catheter-based treatments in heart care.