MDT · News · 20261106N

Renal Denervation Evidence

Medtronic plc · 2026-11-06 · Importance 34 · Surprise 42

Medtronic's Symplicity Spyral system met the primary endpoint in the SPYRAL AFFIRM post-approval study, with statistically significant blood-pressure reductions at six months across office, home, and 24-hour monitoring. The study reported no increase in antihypertensive medications and a 2.1% composite safety event rate. Updated FDA labeling includes additional clinical data for patients with isolated systolic hypertension, chronic kidney disease up to stage 3b, and type 2 diabetes, broadening the evidence base for these high-need patient groups.

Key facts

• Medtronic's SPYRAL AFFIRM post-approval study of the Symplicity Spyral renal denervation system met its primary endpoint, with statistically significant blood pressure reductions at six months across office, home, and 24-hour monitoring. source
• The SPYRAL AFFIRM study reported no increase in antihypertensive medications. source
• The SPYRAL AFFIRM study reported a 2.1% composite safety event rate. source