Primary Endpoint Results Presented From Medtronic’s SPYRAL AFFIRM Postapproval RDN Study

November 3, 2026—Medtronic announced that the SPYRAL AFFIRM postapproval study of its Symplicity Spyral renal denervation (RDN) system met its primary endpoint, demonstrating statistically significant reductions in office, home, and 24-hour ambulatory systolic blood pressure at 6 months in patients with uncontrolled hypertension.

The results were presented as late-breaking data at TCT 2026 and simultaneously published by Kandzari et al in Circulation: Cardiovascular Interventions.

SPYRAL AFFIRM is a prospective, multicenter, single-arm study designed in collaboration with the FDA to evaluate real-world outcomes after RDN in United States patients with uncontrolled hypertension. The study included diverse patient populations and prespecified subgroups, including women, Black and Hispanic patients, and patients aged ≥ 65 years. Six-month results from the United States primary endpoint cohort were compared with a prespecified performance goal.

According to Medtronic’s press release, the study showed the following results at 6 months:

• Office systolic blood pressure decreased by 18.2 ± 22.0 mm Hg from baseline (P < .0001)
• Home systolic blood pressure decreased by 9.4 ± 13.8 mm Hg (P < .0001)
• 24-hour ambulatory systolic blood pressure decreased by 9.7 ± 16.8 mm Hg (P < .0001)
• Similar blood pressure reductions were observed in women, Black and Hispanic patients, and patients aged ≥ 65 years
• Antihypertensive medication use remained unchanged from baseline at 3.6 ± 2.0 medications
• The composite safety endpoint occurred in 2.1% of patients
• Nearly nine out of 10 patients experienced a clinical benefit

“The blood pressure reductions achieved with RDN in the AFFIRM study are transformative. In fact, they are within the range associated with a > 20% reduction in major adverse cardiovascular events, underscoring the clinical significance of these results,” stated David Kandzari, MD, Chief of Piedmont Heart Institute and Cardiovascular Services and Lead Principal Investigator of SPYRAL AFFIRM, in the press release. “Importantly, the study also demonstrated significant reductions in home blood pressure, offering insight into how patients are responding beyond the clinical setting and in their everyday lives. These findings reinforce the potential benefit of renal denervation in combination with lifestyle changes and medication for patients who continue to struggle with uncontrolled hypertension.”

Medtronic also announced FDA approval of updated labeling for the Symplicity Spyral multielectrode RDN catheter. The revised labeling incorporates additional clinical data for patients with isolated systolic hypertension, chronic kidney disease up to stage 3b (estimated glomerular filtration rate ≥ 30 mL/min/1.73 m²), and type 2 diabetes. The device’s indication for use remains unchanged.

According to Medtronic, evidence supporting the labeling update included findings from the SPYRAL HTN clinical program, including SPYRAL AFFIRM and the Global SYMPLICITY Registry DEFINE.