Medtronic's Renal Denervation Device Shows Promising Long-Term Results in Blood Pressure Reduction

Medtronic, a leading medical technology company, has released three-year data for its renal denervation (RDN) device, Symplicity Spyral, demonstrating significant long-term reductions in blood pressure. The results, presented at the 2025 Transcatheter Cardiovascular Therapeutics conference, offer new insights into the potential of RDN as a treatment for hypertension.

Long-Term Efficacy of Symplicity Spyral

The SPYRAL HTN-ON MED trial, which initially missed its primary endpoint in 2022, has now yielded final results showing sustained blood pressure reductions over a three-year period. Patients treated with Symplicity Spyral experienced a 14.0 mmHg decrease in 24-hour ambulatory systolic blood pressure, compared to a 9.3 mmHg reduction in the sham control group. Office-based systolic blood pressure measurements showed even more pronounced effects, with an 18.5 mmHg reduction in the RDN group versus 11.7 mmHg in the sham arm.

While the difference between RDN and control groups narrowed slightly between the second and third years, the benefits of RDN remained statistically significant. Medtronic reported a 4.7 mmHg advantage in 24-hour results and a 7.4 mmHg improvement in office-based measurements for RDN patients after three years, compared to the sham group.

Safety Profile and Regulatory Landscape

The study also addressed safety concerns, reporting no cases of renal artery stenosis greater than 70% in the RDN group. This finding supports the long-term safety profile of Symplicity Spyral, which is contraindicated in patients with baseline renal artery diameter stenosis exceeding 50%.

Symplicity Spyral received FDA approval two years ago, positioning Medtronic to compete with Otsuka's Recor Medical in the RDN market. The Centers for Medicare and Medicaid Services (CMS) proposed a national coverage determination for RDN in July, with cardiologists voicing support for Medicare coverage. However, the final coverage determination, originally due by October 8, has been delayed amid a U.S. government shutdown.

Market Implications and Future Outlook

Medtronic CFO Thierry Piéton has highlighted the potential impact of Medicare coverage on RDN procedures, predicting a significant ramp-up following the final coverage determination. In preparation for anticipated growth, Medtronic is actively hiring clinical specialists and market development personnel to drive future expansion in the RDN sector.

As the medical community awaits the CMS decision, the latest data from the SPYRAL HTN-ON MED trial provides encouraging evidence for the long-term efficacy and safety of renal denervation in managing hypertension. The results may influence both clinical practice and regulatory decisions, potentially reshaping the landscape of hypertension treatment in the coming years.