Medtronic RDN Study Cuts Office BP 18.2 mmHg; FDA Updates Label
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GALWAY – November 03, 2026 -- Medtronic's Symplicity Spyral renal denervation (RDN) system cut office systolic blood pressure by 18.2 mmHg at six months in the SPYRAL AFFIRM post-approval study, with no increase in antihypertensive medication. The company also received U.S. FDA approval to update the device's labeling with additional clinical data.
SPYRAL AFFIRM data show significant reductions across three blood pressure measures
Six-month results in the U.S. primary endpoint cohort were compared with a prespecified performance goal. Against baseline, patients recorded the following changes, all at p<0.0001: