Medtronic (NYSE: MDT) today announced the first results from the high cardiovascular risk cohort of its SPYRAL AFFIRM study.
The medtech giant also completed enrollment in the study of its Symplicity Spyral renal denervation (RDN) system. It shared the first data report at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Findings add to three-year Symplicity Spyral outcomes shared at TCT yesterday.
In the data shared for SPYRAL AFFIRM, investigators saw significant, safe and sustained blood pressure reductions with the RDN system. This occurred with no increase in anti-hypertensive medication use at six months.
Data came from a cohort of 210 patients at 59 sites across Europe, Australia and the U.S. It demonstrated significant reductions in both home and office systolic blood pressure (SBP) across multiple high-risk subgroups. Those included subjects with isolated systolic hypertension (ISH), diabetes mellitus (DM) and chronic kidney disease (CKD).
Medtronic also said that the number of prescribed anti-hypertensive medications remained stable across all groups. Investigators saw no major safety events, further validating the Medtronic Symplicity blood pressure procedure in high-risk patients.
Symplicity Spyral delivers radiofrequency energy to nerves near the kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure. The RDN system holds approval for commercial use in more than 80 countries. Medtronic received a landmark approval for the system in November 2023.
The company said the SPYRAL AFFIRM study has now completed enrollment, too, adding to its body of evidence. This study evaluating safety and efficacy includes a real-world cohort of 987 patients across 100 sites. More than half are enrolled in the U.S.
Commentary from investigators and Medtronic leadership
Dr. Felix Mahfoud, cardiologist at Basel University Heart Center, Switzerland and presenting author of the SPYRAL AFFIRM study, said:
“This first results from the SPYRAL AFFIRM study demonstrates significant, safe, and sustained blood pressure reductions in a high cardiovascular risk patient population that has limited therapeutic options and yet a higher likelihood of adverse events. Seeing positive outcomes in this population underlines why renal denervation is recommended as an adjunctive therapy in U.S. and European hypertension guidelines, helping to reduce blood pressure and improve long-term cardiovascular outcomes.”
Jason Weidman, SVP and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic, said:
“Completing enrollment in the SPYRAL AFFIRM study reinforces our commitment to building the most robust body of real-world evidence in the field of renal denervation. Specifically, this study will allow us to evaluate the technology across clinically diverse and traditionally underserved patient populations — like high cardiovascular risk patients — whose blood pressure remains uncontrolled despite medication and lifestyle modifications.”
