Medtronic Symplicity blood pressure procedure shows significant blood pressure drops in SPYRAL AFFIRM real-world study

Medtronic says primary endpoint results from the SPYRAL AFFIRM post-approval study show statistically significant, clinically meaningful blood pressure reductions at six months for its Symplicity Spyral renal denervation (RDN) system. The company reported decreases measured in office, home, and 24-hour ambulatory readings, with no increase in antihypertensive medications. Nearly nine out of 10 patients experienced clinical benefit at six months, and a pooled analysis replicated the benefit at three years. SPYRAL AFFIRM enrolled U.S. patients with uncontrolled hypertension across diverse subgroups. The findings were presented at TCT 2026 and published in Circulation Cardiovascular Interventions. Separately, the FDA approved an updated U.S. labeling for Symplicity Spyral.