Medtronic’s RDN system approved in Japan
Medtronic has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its Symplicity Spyral Renal Denervation (RDN) System. The technology, designed to treat patients with uncontrolled hypertension, can now be officially bought and sold in Japan.
The news comes just days after Recor Medical gained the same approval for its own RDN system.
“As hypertension continues to pose a growing health challenge in Japan, the demand for advanced and alternative treatment options is becoming increasingly critical, especially for Japan’s aging population,” Jason Weidman, senior vice president and president of the coronary and RDN business at Medtronic, said in a prepared statement. “This year marks 50 years of Medtronic serving patients in Japan. The recent approval by the PMDA underscores our dedication to advancing healthcare innovation and delivering transformative therapies to those in need. We are excited to continue our momentum and leadership in the RDN space by expanding patient and physician access to the Symplicity blood pressure procedure.”
The Symplicity Spyral system first gained U.S. Food and Drug Administration (FDA) approval back in November 2023, making it the second RDN system the FDA ever approved for treating hypertension. The technology works by using radiofrequency energy to ablate overactive renal nerves. It’s a minimally invasive procedure that involves a single catheter.
RDN’s growth in the United States has been one of the biggest ongoing trends in modern healthcare. In fact, the U.S. Centers for Medicare and Medicaid Services (CMS) has proposed providing Medicare coverage on a national level for the use of RDN to treat uncontrolled hypertension. A final decision from CMS is expected in the months ahead.
RDN has gained so much momentum that the American College of Cardiology and American Heart Association just included recommendations for the technology in their new hypertension guidelines.
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.