Medtronic's Symplicity device lowers blood pressure in six-month real-world study
MDT•Medtronic said its SPYRAL AFFIRM study found significant blood pressure reductions six months after treatment with its Symplicity Spyral system, without increased use of blood pressure medication. The FDA cleared a U.S. labeling update adding clinical evidence for patients with isolated systolic hypertension, chronic kidney disease and type 2 diabetes; the indication remains unchanged.
1. Study results and labeling
Medtronic reported significant blood pressure reductions at six months in the SPYRAL AFFIRM study of its Symplicity Spyral renal denervation system, without increased use of blood pressure medication. Reductions were similar across diverse patient groups. The results were presented at TCT 2026 and published in Circulation Cardiovascular Interventions. The FDA also cleared a U.S. labeling update incorporating additional clinical evidence for patients with isolated systolic hypertension, chronic kidney disease and type 2 diabetes; the indication for use remains unchanged.
