Otsuka Medical Devices announced today that Japanese authorities approved the Recor Medical Paradise ultrasound renal denervation (uRDN) system.
Tokyo-based Otsuka’s U.S.-based Recor subsidiary developed Paradise for the treatment of resistant hypertension. Recor Medical received a landmark FDA nod for its Paradise system in November 2023. It also holds CE mark.
“The Paradise uRDN system has been well received by both patients and physicians in the U.S., where it received FDA approval and was launched in November 2023. We are delighted to now offer this innovative treatment option to patients in Japan and contribute to their health and well-being. We remain committed to advancing medical care and supporting patients through innovative solutions.” said Noriko Tojo, president and representative director of Otsuka Medical Devices.
More about the Recor Medical Paradise system
The first-of-its-kind Paradise technology denervates the sympathetic nerves surrounding the renal arteries. This lowers blood pressure by reducing the overactivity that can lead to hypertension.
Paradise delivers two to three doses of 360-degree ultrasound energy, lasting seven seconds each. The energy travels through each of the main renal arteries to the surrounding nerves. Its catheter features the Recor HydroCooling system that circulates sterile water during the procedure to protect the renal artery wall.
Recor currently battles Medtronic and its Symplicity Spyral system in the U.S. market, but today’s approval marks the first in Japan for a medical device indicated for resistant hypertension. The company says it received approval based on results from the RADIANCE-HTN TRIO study in the U.S. and Europe. Recor also has a post-market registry underway in Europe, the UK and the U.S. to collect long-term, post-marketing data. It plans to conduct a post-marketing surveillance study in Japan as well.
“We are pleased that the Paradise uRDN system is the first renal denervation device to be approved in Japan, making it the first treatment of its kind available to patients in the country,” commented Lara Barghout, president and CEO of Recor Medical. “Hypertension knows no global boundaries. Expanding access to this innovative therapy is central to our mission, and we are passionate about providing transformative solutions that improve both the health and quality of life for patients around the world.”
