MDT · News · 20261103N

Renal Denervation Evidence

Medtronic plc · 2026-11-03 · Importance 31 · Surprise 42

Medtronic reported statistically significant and clinically meaningful blood pressure reductions at six months in the SPYRAL AFFIRM post-approval study of its Symplicity Spyral renal denervation system. The results covered office, home, and 24-hour ambulatory blood pressure, without increased use of antihypertensive medications; nearly nine out of 10 patients reportedly experienced clinical benefit. The FDA approved a U.S. labeling update adding clinical data for patients with isolated systolic hypertension, chronic kidney disease up to stage 3b, and type 2 diabetes, while leaving the overall indication unchanged. Results were presented at TCT 2026 and published in Circulation Cardiovascular Interventions.

Key facts

• The FDA approved a labeling update for Medtronic's Symplicity Spyral system adding clinical data for patients with isolated systolic hypertension, CKD up to stage 3b, and type 2 diabetes; the overall indication remains unchanged. source
• SPYRAL AFFIRM findings were presented as late-breaking data at the TCT 2026 annual meeting and simultaneously published in Circulation Cardiovascular Interventions. source
• The SPYRAL AFFIRM study showed statistically significant blood pressure reductions at six months without increased antihypertensive medication use. source
• The SPYRAL AFFIRM study showed statistically significant and clinically meaningful blood pressure reductions at six months in office, home, and 24-hour ambulatory measurements, with no increase in antihypertensive medications. source
• Nearly 90% of patients in the SPYRAL AFFIRM study reportedly experienced clinical benefit. source