Medtronic reports significant blood pressure reductions in SPYRAL AFFIRM study
Real-world data from the SPYRAL AFFIRM study demonstrates sustained blood pressure drops for patients using the Symplicity Spyral renal denervation system.
Medtronic has released primary endpoint data from its SPYRAL AFFIRM study, showing that the Symplicity Spyral renal denervation (RDN) system achieved clinically meaningful blood pressure reductions at six months. The results, presented at the TCT 2026 meeting, indicated consistent drops in office, home, and 24-hour ambulatory blood pressure measurements among patients with uncontrolled hypertension.
The multicenter study, which tracked patients across diverse demographic groups, reported that blood pressure decreased without an accompanying increase in medication use. Lead investigator Dr. David Kandzari noted that the reduction levels are in a range typically associated with a decreased risk of major adverse cardiovascular events.
In conjunction with these findings, the U.S. Food and Drug Administration (FDA) approved an update to the labeling of the Symplicity Spyral catheter. This update incorporates additional clinical evidence regarding treatment for patients with chronic kidney disease, type 2 diabetes, and isolated systolic hypertension, providing physicians with more specific data for treatment planning.
The Symplicity RDN system is currently utilized in over 80 countries. Medtronic stated that these results reinforce the potential role of renal denervation as a complementary therapy alongside medication and lifestyle adjustments.