Medtronic plc announced that Japan's Ministry of Health, Labour and Welfare has approved reimbursement for the Symplicity Spyral renal denervation system for patients with resistant hypertension. The move establishes a funding pathway for a minimally invasive procedure that targets overactive renal nerves believed to contribute to elevated blood pressure.
The Symplicity blood pressure procedure employs a catheter-based approach to deliver radiofrequency energy to nerves near the kidneys with the objective of reducing their activity. Medtronic describes the therapy as a minimally invasive alternative for patients whose blood pressure remains uncontrolled despite treatment.
Hypertension represents a substantial public health challenge in Japan. The company reports that roughly 43 million adults in the country have hypertension, while treatment and control rates lag: about 60% of diagnosed patients receive treatment, and among those treated fewer than half achieve adequate blood pressure control.
Jason Weidman, Senior Vice President and President, Coronary & Renal Denervation at Medtronic, commented on the ministry's decision, saying, "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." The statement frames the reimbursement approval as a means to expand patient access.
Clinical evidence cited by Medtronic includes results from the SPYRAL HTN-ON MED study, which demonstrated a 17.4 mmHg reduction in office systolic blood pressure for patients treated with the Spyral system through two years, a reduction described as significantly greater than that observed in the sham control group. The company's SPYRAL HTN clinical program has enrolled more than 5,000 patients across studies that included participants both taking and not taking antihypertensive medications, and enrolling individuals with high baseline cardiovascular risk.
Medtronic also reports broader global experience with the technology, noting more than 30,000 patients treated worldwide and commercial approvals for the Symplicity Spyral Renal Denervation System in nearly 80 countries.
Key takeaways
- Japan's health ministry granted reimbursement approval for Medtronic's Symplicity Spyral renal denervation system for resistant hypertension.
- The procedure uses catheter-delivered radiofrequency energy to target renal nerves and has shown a 17.4 mmHg office systolic blood pressure reduction through two years in the SPYRAL HTN-ON MED trial.
- Hypertension affects an estimated 43 million adults in Japan, with treatment and control rates reported as suboptimal, and the device is commercially approved in nearly 80 countries with global experience in over 30,000 patients.
Risks and uncertainties
- Hypertension prevalence and low control rates in Japan highlight a significant unmet need; the scale of that need and how many patients will access the procedure under the new reimbursement framework is not specified in the announcement.
- The clinical result cited reflects office systolic blood pressure reduction through two years in a specific trial; longer-term outcomes beyond that timeframe are not detailed in the statement.
- While reimbursement approval in Japan establishes coverage, the announcement does not provide details on the scope of coverage, patient eligibility criteria, or how broadly the therapy will be implemented within clinical practice.