Long-Term SPYRAL HTN-ON MED Data Presented for Medtronic’s Symplicity Spyral RDN System

October 26, 2025—Medtronic announced that long-term results from its final report of the SPYRAL HTN-ON MED trial showed that patients treated with the company’s radiofrequency-based Symplicity Spyral renal denervation (RDN) procedure experienced significantly greater reductions in blood pressure compared to sham patients through 3 years.

According to Medtronic, the global, randomized, sham-controlled trial investigated the blood pressure lowering effect and safety of RDN with the Symplicity system in hypertensive patients who have been prescribed up to three antihypertensive medications.

After the 6-month primary endpoint assessment, the study continued to assess 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) from baseline through yearly follow ups, noted the company.

The new data were presented at the TCT 2025 scientific symposium.

Medtronic reported that at 3 years, patients who underwent RDN (n = 206) showed significantly greater reductions in both 24-hour ABPM and OSBP compared to sham patients (n = 131), despite similar medication burden.

In the RDN group compared with the sham group, 24-hour ABPM was –14.0 mm Hg versus –9.3 mm Hg (treatment difference: –4.7 mm Hg; P = .0028) and OSBP was –18.5 mm Hg versus –11.7 mm Hg (treatment difference: –7.4 mm Hg; P = .0002).

Additionally, no renal artery stenosis > 70% was observed in the RDN group through 3 years, supporting the long-term safety of the Symplicity Spyral RDN system, noted Medtronic.

David Kandzari, MD, who is Coprincipal Investigator of the SPYRAL clinical program, commented on the findings in the company’s press release.

“Radiofrequency renal denervation with the Symplicity blood pressure procedure continues to demonstrate a durable and clinically meaningful blood pressure–lowering effect,” stated Dr. Kandzari. “Through 3 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.”