Recor Medical gains historic approval for its ultrasound RDN system
Recor Medical, a wholly owned subsidiary of Otsuka Medical Devices, has announced that its Paradise Ultrasound Renal Denervation (RDN) System is the first medical device approved for the treatment of hypertension in Japan.
Japanese officials decided to approve the Paradise RDN system came after reviewing data from the RADIANCE-HTN TRIO study, which evaluated the safety and effectiveness of ultrasound RDN compared to a sham procedure in patients resistant to traditional pharmaceutical treatments. A post-marketing surveillance study will also be conducted in Japan to track the system’s long-term value.
“We are pleased that the Paradise Ultrasound RDN system is the first RDN device to be approved in Japan, making it the first treatment of its kind available to patients in the country,” Lara Barghout, president and CEO of Recor Medical, said in a statement. “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.”
“Hypertension is a leading cause of cardiovascular diseases, which are among the top three causes of death in Japan,” added Yoshio Kobayashi, president of the Japanese Circulation Society and professor of cardiovascular medicine at Chiba University Graduate School of Medicine. “We are hopeful that the Paradise Ultrasound RDN system will expand treatment possibilities and contribute to the prevention of cardiovascular events.”
The Paradise system first gained U.S. Food and Drug Administration (FDA) approval back in November 2023. At the time, it was the first RDN system the FDA ever approved for treating hypertension. The technology works by ablating overactive renal nerves with ultrasound energy in a way that helps lower a patient’s blood pressure. Its growth in the United States has been so significant that the American College of Cardiology and American Heart Association just included recommendations for RDN in their new hypertension guidelines.
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