Renal Denervation: Is it Still Promising? A/Prof Michael Nguyen Fiona Stanley Hospital Australia Medtronic SYMPLICITY HTN-3 Announcement January 9th Announcement • Primary efficacy endpoint was not met • Powered safety endpoint was met The Symplicity™ renal denervation system is not approved for sale in the US For distribution only in markets where the Symplicity™ renal denervation system has been approved Not for distribution in the USA, Japan or France © 2014 Medtronic, Inc All rights reserved UC201502039bML 8/14 SYMPLICITY HTN-3 Primary Efficacy Endpoint ∆SBP at Month Office Systolic Blood Pressure at Months, mm Superiority Margin -4 RDN Control n=353 n=171 -8 -12 -16 -11.7 -14.1 RDN Control P value Baseline SBP 179.7 180.2 0.765 mo SBP 165.6 168.4 0.260 -14.1 P