Medtronic reports significant blood pressure reductions in SPYRAL AFFIRM study

Medtronic has announced primary endpoint results from its SPYRAL AFFIRM post-approval study, which evaluated the Symplicity Spyral renal denervation (RDN) system. The prospective, multicenter study, conducted in collaboration with the FDA, focused on real-world outcomes for patients in the United States with uncontrolled hypertension.

At the six-month mark, the study demonstrated statistically significant reductions in office, home, and 24-hour ambulatory systolic blood pressure. Specifically, mean office systolic blood pressure decreased by 18.2 mm Hg from baseline. Reductions were also observed in home blood pressure and 24-hour ambulatory blood pressure. Notably, these results were achieved without an increase in the use of antihypertensive medications.

The study included diverse patient populations, including women, Black and Hispanic patients, and individuals aged 65 and older. Data presented at the TCT 2026 annual meeting and published in Circulation: Cardiovascular Interventions indicated that nearly nine out of 10 patients experienced clinical benefits at six months, with pooled analysis replicating these benefits at three years.