DUBLIN and CHICAGO, November 7, 2022 /PRNewswire/ — Medtronic plc MDT, a global leader in healthcare technology, today announced six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The data were presented today as “Late-Breaking Clinical Science” at the American Heart Association (AHA) Scientific Sessions 2022. With this news, Medtronic has submitted the final module of the Symplicity Spyral™ Premarket Approval (PMA) package to the US Food and Drug Administration (FDA) for review and approval.
Subjects prescribed antihypertensive medications and treated with Medtronic’s Symplicity Spyral Renal Denervation (RDN) System had a statistically significant and clinically meaningful reduction in systolic blood pressure (OSBP), a key secondary endpoint, compared to subjects on sham therapy , on control group. However, for the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM) due to increased medication in the sham control group and the potential impact of the Covid-19 pandemic on the clinical study setting. The study also included win ratio, a pre-specified secondary endpoint that combines a reduction in blood pressure with a reduction in medication burden, allowing for an assessment of the overall beneficial effect of RDN. The win ratio showed significance in favor of RDN over a sham procedure. Finally, the study met its primary safety…
