Medtronic Reports Blood Pressure Reduction of Up to 18.2 mmHg in SPYRAL AFFIRM Study
Key Facts
Medtronic announced results from the SPYRAL AFFIRM study on November 3, 2026, saying mean office-measured systolic blood pressure fell 18.2 ± 22.0 mmHg after six months, with statistical significance at p<0.0001. The company said the results support an update to the Symplicity Spyral device label with data from post-approval studies. The update adds clinical evidence for patient groups at elevated risk, while the device’s approved indication remains unchanged. Results also showed declines in home and all-day measurements, offering a broader view of the change recorded during follow-up. Medtronic shares, listed under the ticker MDT, closed at $99.29 in the November 2 session, according to EL7 data.
In home measurements, mean blood pressure fell 9.4 ± 13.8 mmHg after six months, with p<0.0001, according to company data. Mean 24-hour ambulatory blood pressure fell 9.7 ± 16.8 mmHg over the same period, also with p<0.0001. These measurements provide complementary indicators of blood pressure changes beyond the office reading, covering home measurement and extended monitoring throughout the day. Medtronic said the mean number of antihypertensive medications remained at 3.6 ± 2.0, with no increase from baseline. The company said, "Nearly 9 out of 10 patients achieved clinical benefit after six months." It added that a separate pooled analysis replicated the clinical benefit at three years.
On safety, the composite endpoint occurred in 2.1% of patients, according to Medtronic’s announcement. Data added to the label included patients with isolated systolic hypertension, type 2 diabetes, and chronic kidney disease through stage 3b, provided their glomerular filtration rate was at least 30 mL/min/1.73 m². The company said including these groups broadens the data presented in the label, while the indication remains unchanged. The Food and Drug Administration defines the system’s use as an adjunctive treatment to lower blood pressure in patients whose hypertension is not adequately controlled by lifestyle changes and antihypertensive medications. The update therefore adds information about outcomes in specific groups to the label, without changing the population covered by the indication.
The broader clinical context draws on an analysis of 210 patients at high cardiovascular risk out of 987 patients who underwent renal denervation between October 2021 and August 2025. The analysis included groups with diabetes, chronic kidney disease, and isolated systolic hypertension. At baseline, mean office systolic blood pressure was 162 ± 19 mmHg and home systolic blood pressure was 154 ± 15 mmHg, while the mean number of antihypertensive medications was 3.8 ± 1.8. After six months, office blood pressure fell 13.3 ± 21.5 mmHg among patients with diabetes, 19.3 ± 24.5 among patients with stage 3b chronic kidney disease, and 10.6 ± 22.1 among those with isolated systolic hypertension. The analysis said the glomerular filtration rate in the chronic kidney disease group remained stable.
Medtronic had announced results from the high-risk cohort on October 27, 2025, comprising 210 patients from 59 sites in Europe, Australia and the United States. The company said at the time that the data showed declines in office- and home-measured blood pressure among the diabetes, isolated systolic hypertension and chronic kidney disease groups, without an increase in medication use. The more recent results were presented as late-breaking data at the 2026 annual meeting of Cardiovascular Interventions and published simultaneously in the journal "Circulation: Cardiovascular Interventions." That citation shows the announcement combined a scientific presentation at the meeting with simultaneous publication in a specialist journal. Follow-up of participants in the post-approval study is continuing despite the completion of patient enrollment, Medtronic said.
The Food and Drug Administration recorded supplement S014 for the label change and inclusion of post-approval study data. The agency’s database shows the application was received on January 28, 2026, and the decision was issued on September 10, 2026. These dates place the regulatory action before Medtronic announced the study results in November, while the agency record identifies the supplement’s purpose as a label change. Meanwhile, follow-up in the SPYRAL AFFIRM study is continuing after enrollment was completed. The announced results provide blood pressure readings from office, home and ambulatory monitoring, alongside safety and medication data over the six-month period.