Medtronic (NYSE: MDT) today announced new long-term results from its final report of the SPYRAL HTN-ON MED trial.
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure-lowering effect and safety of renal denervation (RDN) with the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications. After the six-month primary endpoint assessment, the study continued to assess 24-hr ABPM and OSBP from baseline through yearly follow-ups.
Symplicity Spyral delivers radiofrequency energy to nerves near the kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure.
The RDN system holds approval for commercial use in more than 80 countries. Medtronic received a landmark approval for the system in November 2023.
About one year ago, the company reported two-year data that fell in line with other long-term findings for Symplicity. It demonstrated clinically meaningful, consistent and sustained blood pressure reductions.
Today, the medtech giant — one of the largest medical device companies in the world — shared three-year findings during the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Dr. David Kandzari, the SPYRAL clinical program’s co-principal investigator, said the system “continues to demonstrate a durable and clinically meaningful blood pressure-lowering effect.
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At three years, 206 patients who underwent RDN showed significantly greater reductions in both 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared to 131 sham patients, despite similar medication burden.
Medtronic also reported no renal artery stenosis greater than 70% in the RDN group through three years. Renal artery stenosis occurs when the arteries that supply blood to the kidneys narrow. The company said this supports the long-term safety profile for Symplicity Spyral.
“These results further underscore the consistent and durable effects of the Symplicity blood pressure procedure, with the most long-term data presented and published to date,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “With more than 5,000 patients studied and over 30,000 procedures performed globally, the Symplicity blood pressure procedure continues to set the standard in renal denervation by offering a safe, effective, and lasting option for patients whose blood pressure remains uncontrolled despite medications and lifestyle modifications, and who are interested in an interventional approach to control their blood pressure.”
