The Minnesota-run medtech giant announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved reimbursement for the system.
“This decision enables broader access to a therapy that has been shown to provide sustained reductions in blood pressure and improve outcomes for patients with hypertension,” Jason Weidman, SVP and president of Coronary & Renal Denervation at Medtronic, said in a news release. “We are proud to continue our 50-year legacy of serving patients in Japan through innovation and collaboration.”
The news comes more than five months after the country’s Pharmaceuticals and Medical Devices Agency (PMDA) approved the blood pressure procedure for the treatment of resistant hypertension. Medtronic’s main RDN competition, Recor Medical, won approval in Japan for its Paradise platform around the same time.
Symplicity Spyral and Paradise have both been U.S. FDA approved since late 2023, with a CMS National Coverage Determination (NCD) in 2025 supporting reimbursement.
When it comes to Symplicity Spyral, Medtronic has launched a direct-to-consumer marketing campaign, plans to launch a transradial catheter for the system in the second half of the next fiscal year, and the Spyral Gemini trial is evaluating multi-organ ablation to boost efficacy.
During Medtronic’s Q3 earnings call on Feb. 17, CEO Geoff Martha said the company’s direct-to-consumer website for Symplicity had 2.5 million visits in Q3, up from 50,000 in Q2.
“The consumer demand is really spiking here, and we’re just getting started,” Martha said. “Most importantly, we’re getting terrific patient outcomes, with the blood pressure coming down meaningfully. … It’s really resonating with patients, and that, in and of itself, is getting doctors excited.”
Medical Design & Outsourcing: Learn how Medtronic and other major OEMs developed their PFA systems in MDO’s Nitinol Innovation Special Report
