Medtronic's Symplicity Spyral Renal Denervation System Shows Significant Blood Pressure Reduction in Real-World Study; FDA Approves Labeling Update

Primary endpoint results from the SPYRAL AFFIRM post-approval study of Medtronic's Symplicity Spyral renal denervation (RDN) system demonstrated statistically significant and clinically meaningful reductions in office, home, and 24-hour ambulatory blood pressure at six months, with no increase in antihypertensive medications. The FDA also approved an update to the system's labeling to include additional clinical data in patients with isolated systolic hypertension, chronic kidney disease up to stage 3b, and type 2 diabetes.