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September 2, 2025
Medtronic’s Symplicity Spyral Renal Denervation System Approved in Japan
September 2, 2025—Medtronic announced that its Symplicity Spyral renal denervation (RDN) system has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of resistant hypertension. The company will now initiate the process to obtain approval for insurance coverage in Japan.
The Symplicity Spyral RDN system is now approved for commercial use in 77 countries around the world, noted the company.
According to the company, Medtronic clinical trials, including the SPYRAL HTN-ON MED study, showed 24-month office systolic blood pressure reduction of 17.4 mm Hg in Spyral patients through 2 years and a significantly greater reduction versus sham. The SPYRAL HTN clinical program is a real-world registry that comprises more than 5,000 patients showing long-term reductions without the need for additional medication.
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