GALWAY – November 03, 2026 -- Medtronic's Symplicity Spyral renal denervation (RDN) system cut office systolic blood pressure by 18.2 mmHg at six months in the SPYRAL AFFIRM post-approval study, with no increase in antihypertensive medication. The company also received U.S. FDA approval to update the device's labeling with additional clinical data.
SPYRAL AFFIRM data show significant reductions across three blood pressure measures
Six-month results in the U.S. primary endpoint cohort were compared with a prespecified performance goal. Against baseline, patients recorded the following changes, all at p<0.0001:
- Office systolic blood pressure: -18.2 ± 22.0 mmHg
- Home blood pressure: -9.4 ± 13.8 mmHg
- 24-hour ambulatory blood pressure: -9.7 ± 16.8 mmHg
Patients averaged 3.6 ± 2.0 antihypertensive medications, unchanged from baseline through six months. The composite safety endpoint occurred in 2.1% of patients. Nearly nine out of 10 patients experienced a clinical benefit at six months. A separate pooled analysis replicated that benefit at three years, according to a March 2026 EuroIntervention publication.
Reductions were similar in women, Black American and Hispanic patients, and patients 65 and older.
Study was designed with the FDA to capture real-world U.S. evidence
SPYRAL AFFIRM is a prospective, multicenter, single-arm study designed with the FDA. It covers U.S. patients with uncontrolled hypertension across diverse populations and clinically relevant subgroups. The results were presented as late-breaking data at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 annual meeting and published simultaneously in Circulation Cardiovascular Interventions.
Lead principal investigator Dr. David Kandzari, chief of Piedmont Heart Institute and Cardiovascular Services, said the reductions fall within the range associated with a greater than 20% reduction in major adverse cardiovascular events. He also noted that the home blood pressure reductions show how patients respond outside the clinic.
FDA approves labeling update covering ISH, CKD up to stage 3b and type 2 diabetes
The updated labeling for the Symplicity Spyral Multi-Electrode Renal Denervation Catheter adds clinical data for patients with isolated systolic hypertension, chronic kidney disease up to stage 3b (eGFR ≥30 mL/min/1.73 m2) and type 2 diabetes. The indication for use remains unchanged.
Evidence from the SPYRAL HTN clinical program supported the update, including SPYRAL AFFIRM and the Global SYMPLICITY Registry DEFINE. Lara Barghout, senior vice president and president of Interventional Cardiology Therapies at Medtronic, said the update gives physicians additional information to guide treatment for patients with hypertension and high cardiovascular risk.
The Symplicity RDN system is approved for commercial use in more than 80 countries.