Medtronic reports positive SPYRAL AFFIRM study results; FDA approves Symplicity Spyral labeling update

Medtronic reported statistically significant blood pressure reductions at six months in the SPYRAL AFFIRM study, with no increase in antihypertensive medications. The FDA approved a labeling update for the Symplicity Spyral system adding the clinical data for patients with isolated systolic hypertension, chronic kidney disease and type 2 diabetes.

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Medtronic plcFood and Drug Administration

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