Medtronic Presents Six-Month (SPYRAL HTN-ON MED) Study Results of Symplicity Spyral Renal Denervation System for Hypertension at AHA 2022
Shots:
- The (SPYRAL HTN-ON MED) trial evaluates Symplicity Spyral RDN System vs sham control in a ratio (2:1) in 337 hypertensive patients who have been prescribed up to 3 anti-hypertensive medications at 42 sites across the US, EU & other countries
- The primary efficacy EPs of 24hr. systolic ABPM reduction was not met with a 51% probability of superiority & nighttime systolic ABPM reduction was statistically significant. The study met the prespecified 2EPs i.e., change in OSBP from baseline to 6mos. follow-up
- The study met the primary safety EPs i.e., AEs @1mos. post-procedure, and renal artery stenosis @6mos., pooled across the (SPYRAL HTN-ON) & (OFF MED) studies. The system has been approved in 60+ countries globally & limited to investigational use in the US, Japan & Canada
Ref: PRNewswire | Image: Medtronic
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