Ultrasound RDN system launches in Japan—cardiologist calls it a ‘significant step forward’
Recor Medical’s Paradise Ultrasound Renal Denervation (RDN) system is now covered by National Health Insurance in Japan as a treatment option for patients with resistant hypertension.
Otsuka Medical Devices, Recor Medical’s parent company, and Otsuka Pharmaceutical announced the approval on March 2. With insurance coverage in place, Otsuka Medical Devices is now selling the Paradise Ultrasound technology throughout Japan.
The Paradise Ultrasound RDN system uses ultrasound energy to treat resistant hypertension, delivering seven-second bursts to the patient’s renal arteries. This penetrates the tissue at a depth of up to 6 mm, ablating overactive sympathetic nerves all around the artery. The U.S. Food and Drug Administration (FDA) approved this technology in November 2023. At the time, it was the very first RDN system to gain approval.
“I am delighted that we can provide a new option to address the medical challenge of resistant hypertension by leveraging the know-how cultivated through the Otsuka group's pharmaceutical business,” Makoto Inoue, president of both Otsuka Holdings and Otsuka Pharmaceutical, said in a statement. “Moving forward, we will bring together the collective strength of the Otsuka group to deliver optimal solutions for patients and consumers, as we strive to contribute to the total healthcare of every individual.”
“Resistant hypertension carries an extremely high risk of leading to serious complications, such as cerebrovascular and cardiovascular diseases and renal failure,” added cardiologist Kazuomi Kario, MD, PhD, president of the Japanese Society of Hypertension and a professor of cardiovascular medicine at Jichi Medical University. “Being able to provide appropriate treatment opportunities to patients in need through this insurance coverage marks a significant step forward. 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.”
RDN technologies are taking off in Japan, which is home to an estimated 43 million adults with hypertension. Medtronic recently announced that its own RDN system was approved for reimbursement in the country.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.