Medtronic announced three-year results from the SPYRAL HTN-ON MED randomized clinical trial showing that patients treated with the Symplicity Spyral renal denervation (RDN) procedure experienced significantly greater blood pressure reductions compared to sham patients. The data were presented during the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference.
Sustained Blood Pressure Reductions Demonstrated
At three years, patients who underwent RDN (N=206) showed significantly greater reductions in both 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared to sham patients (N=131), despite similar medication burden.
The treatment group achieved a 14.0 mmHg reduction in 24-hour ABPM versus 9.3 mmHg in the sham group, representing a treatment difference of 4.7 mmHg (p=0.0028). For office-based measurements, the RDN group demonstrated an 18.5 mmHg reduction compared to 11.7 mmHg in the sham group, with a treatment difference of 7.4 mmHg (p=0.0002).
"Radiofrequency renal denervation with the Symplicity blood pressure procedure continues to demonstrate a durable and clinically meaningful blood pressure–lowering effect," said David Kandzari, M.D., chief of Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. "Through three years, sustained reductions in blood pressure were observed among subjects treated with the Symplicity Spyral RDN system, including those from the treatment arm and the approximately three quarters of patients from the control arm that were later treated with Symplicity."
Safety Profile Maintained
The long-term safety data showed no renal artery stenosis greater than 70% was observed in the RDN group through three years, supporting the safety profile of the Symplicity Spyral RDN system. Renal artery stenosis refers to a narrowing of the arteries that supply blood to the kidneys.
Clinical Trial Design and Global Experience
SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Symplicity 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-hour ABPM and OSBP from baseline through yearly follow-ups.
Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic, noted that the results represent "the most long-term data presented and published to date." He emphasized that 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.
Market Access and Clinical Application
The Symplicity RDN system is approved for commercial use in nearly 80 countries around the world. The procedure offers a treatment 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.
