Medtronic has announced new, long-term results from its final report of the SPYRAL HTN-ON MED randomised clinical trial, showing that patients treated with the Symplicity Spyral renal denervation (RDN) procedure experienced significantly greater reductions in blood pressure compared to sham patients through three years.
The data were presented as part of featured clinical research during the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference (25–28 October, San Francisco, USA).
“Radiofrequency renal denervation with the Symplicity blood pressure procedure continues to demonstrate a durable and clinically meaningful blood pressure–lowering effect,” said David Kandzari (Piedmont Heart Institute and Cardiovascular Service, Atlanta, USA), co-principal investigator of the SPYRAL clinical programme. “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.”
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.
Additionally, no renal artery stenosis greater than 70% was observed in the RDN group through three years.
“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, senior vice president 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.”
SPYRAL HTN-ON MED is a global, randomised, 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.
