Medtronic’s Symplicity Spyral renal denervation system shows major blood‑pressure drops and gains FDA labeling update
Medtronic reported that its Symplicity Spyral renal denervation system lowered office systolic blood pressure by 18.2 mmHg, home blood pressure by 9.4 mmHg and 24‑hour ambulatory pressure by 9.7 mmHg after six months in the SPYRAL AFFIRM real‑world study. Nearly nine out of ten patients experienced a clinical benefit and the composite safety endpoint occurred in 2.1% of participants. The U.S. FDA approved an updated label that adds data for patients with isolated systolic hypertension, chronic kidney disease stage 3b and type 2 diabetes, while the indication remains unchanged.
Why it matters
The FDA labeling update expands the clinical evidence base for the procedure, which may encourage broader physician adoption and support revenue growth for Medtronic’s hypertension portfolio (the company notes the update gives physicians additional information to guide treatment decisions).
Key facts
- 1Office systolic blood pressure fell by 18.2 ± 22.0 mmHg (p<0.0001) at six months. prnewswire.com
- 2Home blood pressure fell by 9.4 ± 13.8 mmHg (p<0.0001) at six months. prnewswire.com
- 324‑hour ambulatory blood pressure fell by 9.7 ± 16.8 mmHg (p<0.0001) at six months. prnewswire.com
- 4Nearly nine out of ten patients experienced a clinical benefit at six months. prnewswire.com
- 5The composite safety endpoint occurred in 2.1% of patients. prnewswire.com
- 6No increase in antihypertensive medications was observed (3.6 ± 2.0 medications, unchanged from baseline). prnewswire.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.