Medtronic Reports Positive SPYRAL AFFIRM Study Results and FDA Labeling Update

Medtronic reported statistically significant blood pressure reductions at six months in the SPYRAL AFFIRM study, with no increase in antihypertensive medication use; nearly 9 in 10 patients experienced clinical benefit. The FDA approved a labeling update for the Symplicity Spyral system adding study data for patients with isolated systolic hypertension, chronic kidney disease up to stage 3b, and type 2 diabetes. The update does not change the system’s approved indication, but expands the clinical evidence available to physicians.