Medtronic announces six-month results from SPYRAL HTN-ON MED trial

Medtronic announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The data were presented as Late-Breaking Clinical Science at the American Heart Association Scientific Sessions 2022. With this news, Medtronic has submitted the final module of the Symplicity Spyral Premarket Approval package to the U.S. FDA for review and approval. Subjects who were prescribed antihypertensive medications and were treated with the Medtronic Symplicity Spyral Renal Denervation System had a statistically significant and clinically meaningful reduction in office-based systolic blood pressure, a key secondary endpoint, compared to subjects in the sham control group. However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure due to increased medications in the sham control group and the potential impacts of the Covid-19 pandemic on the clinical trial environment. The study also included Win Ratio, a pre-specified secondary endpoint that combines reduction in blood pressure with reduction in medication burden, which enables assessment of the overall beneficial effect of RDN. The Win Ratio demonstrated significance in favor of RDN versus a sham procedure. Finally, the study met its primary safety endpoint, with a low incidence of procedure-related and clinical adverse events.