TCT26: Medtronic Symplicity blood pressure procedure shows significant blood pressure drops in SPYRAL AFFIRM real-world study
PR Newswire•03/11/2026•14:35 ET
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Key Highlights
- ➤FDA approved Symplicity labeling update covering ISH, CKD through stage 3b, and type 2 diabetes
- ➤Office systolic blood pressure fell 18.2 mmHg at six months, p<0.0001
- ➤Home blood pressure fell 9.4 mmHg at six months, p<0.0001
- ➤24-hour ambulatory blood pressure fell 9.7 mmHg at six months, p<0.0001
- ➤Composite safety endpoint occurred in 2.1% of patients; nearly nine in 10 benefited
Expert Statements
David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL AFFIRM study
“The blood pressure reductions achieved with RDN in the AFFIRM study are transformative. In fact, they are within the range associated with a greater than 20% reduction in major adverse cardiovascular events, underscoring the clinical significance of these results.”
David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL AFFIRM study
“Importantly, the study also demonstrated significant reductions in home blood pressure, offering insight into how patients are responding beyond the clinical setting and in their everyday lives. These findings reinforce the potential benefit of renal denervation in combination with lifestyle changes and medication for patients who continue to struggle with uncontrolled hypertension.”
Lara Barghout, Senior vice president and president of Interventional Cardiology Therapies at Medtronic
“Generating robust clinical evidence across broad and diverse patient populations remains central to our mission of improving outcomes for people living with hypertension.”
Lara Barghout, Senior vice president and president of Interventional Cardiology Therapies at Medtronic
“Backed by data from SPYRAL AFFIRM and our broader clinical program, this labeling update gives physicians additional information to guide treatment decisions for patients living with hypertension and high cardiovascular risk.”
TCT26: Medtronic Symplicity blood pressure procedure shows significant blood pressure drops in SPYRAL AFFIRM real-world study PR Newswire
Nearly nine out of 10 patients experienced a clinical benefit at six months
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