Advertisement
Advertisement
February 19, 2026
Medtronic Secures Japan Reimbursement for Spyral RDN
February 19, 2026—Medtronic plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted reimbursement approval for the Symplicity Spyral renal denervation (RDN) system (Medtronic) for the treatment of resistant hypertension.
KEY TAKEAWAYS
- Japan’s Ministry of Health, Labour and Welfare granted reimbursement approval for the Symplicity Spyral renal denervation system for resistant hypertension.
- In SPYRAL HTN-ON MED, 24-month office systolic blood pressure reduction was 17.4 mm Hg in treated patients, with significantly greater reduction versus sham.
- The SPYRAL HTN global clinical program has enrolled > 5,000 patients, with reported experience in > 30,000 patients worldwide.
According to the company’s press release, the decision expands access in Japan to catheter-based RDN, a device-based therapy intended to complement antihypertensive medications and lifestyle modification in patients with persistently elevated blood pressure. Hypertension affects approximately 43 million adults in Japan; about 60% of diagnosed patients receive treatment, and fewer than half of those treated achieve adequate blood pressure control.
The Symplicity procedure is described as a minimally invasive, catheter-based intervention that delivers radiofrequency energy to modulate sympathetic nerves surrounding the renal arteries. After sedation, a catheter is advanced into the renal artery, and radiofrequency energy is delivered to reduce renal sympathetic nerve activity. The catheter is then removed, and no implant remains in the body.
Medtronic cited results from the SPYRAL HTN-ON MED study demonstrating a 24-month office systolic blood pressure reduction of 17.4 mm Hg in patients treated with the Symplicity Spyral system, with significantly greater reductions compared with sham control. The broader SPYRAL HTN clinical program includes more than 5,000 patients studied in the presence and absence of antihypertensive medications and in those with high baseline cardiovascular risk, according to the company. Medtronic also reported experience in more than 30,000 patients globally and noted that the system is approved for commercial use in nearly 80 countries.
Advertisement
Advertisement