Medtronic (NYSE: MDT) announced that it received regulatory approval in Japan for its Symplicity Spyral renal denervation (RDN) system.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted approval for the blood pressure procedure for the treatment of resistant hypertension. Medtronic now plans to initiate the process to obtain approval for insurance coverage in the geography as well.
Approval in Japan means Symplicity Spyral is approved for commercial use in more than 75 countries.
This approval comes just a week after the company’s main RDN competition, Recor Medical, won approval in Japan for its Paradise platform. The two companies have been battling in the RDN space for years after Recor received a landmark FDA nod for the Paradise ultrasound RDN (uRDN) system in November 2023. Medtronic, the second company with such approval, picked up its nod for the Symplicity Spyral system just weeks later. The companies also have ongoing patent litigation related to their RDN systems.
Medtronic designed Symplicity Spyral as a minimally invasive procedure that uses a single thin tube to deliver radiofrequency energy to calm the nerves near the kidneys that can become overactive and cause elevated blood pressure.
After sedation, the doctor inserts a single catheter into the artery leading to the kidney. Once inserted, the doctor administers energy to the system to calm the excessive activity of nerves connected to the kidney. The device is then removed, leaving no implant behind.
“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,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic. “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.”
