Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced final results from the SPYRAL HTN-ON MED randomized clinical trial, demonstrating that patients treated with the Symplicity™ Spyral renal denervation (RDN) procedure achieved significantly greater and sustained reductions in blood pressure through three years compared to sham-treated patients.
The data were presented as part of Featured Clinical Research during the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference.
Long-Term Efficacy and Safety
At the three-year mark, patients who underwent RDN (N=206) showed a significantly greater reduction in both 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared with sham-treated patients (N=131), despite similar medication use:
- 24-hour ABPM: −14.0 mmHg in the RDN group vs. −9.3 mmHg in the sham group (difference: −4.7 mmHg; p=0.0028)
- OSBP: −18.5 mmHg in the RDN group vs. −11.7 mmHg in the sham group (difference: −7.4 mmHg; p=0.0002)
No cases of renal artery stenosis exceeding 70% were observed in the RDN group through three years, underscoring the long-term safety of the Symplicity Spyral RDN system.
“Radiofrequency renal denervation with the Symplicity procedure continues to show durable and clinically meaningful blood pressure–lowering effects,” said Dr. David Kandzari, Chief of the Piedmont Heart Institute and co-principal investigator of the SPYRAL clinical program. “Sustained reductions were seen across both the treatment group and the majority of control patients who later underwent the Symplicity procedure.”
“With more than 5,000 patients studied and over 30,000 procedures performed globally, the Symplicity system continues to demonstrate consistent, long-term benefits,” said Jason Weidman, Senior Vice President and President of Medtronic’s Coronary and Renal Denervation business. “These results reaffirm the therapy’s potential as a safe, effective, and lasting option for patients with uncontrolled hypertension despite medication and lifestyle changes.”
About the SPYRAL HTN-ON MED Trial
The SPYRAL HTN-ON MED study is a global, randomized, sham-controlled trial evaluating the blood pressure–lowering effect and safety of Medtronic’s radiofrequency-based Symplicity RDN system in hypertensive patients taking up to three antihypertensive medications.
Following the six-month primary endpoint assessment, patients were monitored annually for 24-hour ABPM and OSBP outcomes. The Symplicity RDN system is currently approved for commercial use in nearly 80 countries worldwide.
About Medtronic
Medtronic plc, headquartered in Galway, Ireland, is one of the world’s leading healthcare technology companies, employing more than 95,000 people across 150+ countries. Its portfolio spans over 70 health conditions, including cardiac devices, surgical robotics, insulin pumps, surgical tools, and patient monitoring systems.
Guided by its mission to alleviate pain, restore health, and extend life, Medtronic delivers technologies that impact two patients every second worldwide
