OUTCOMES WITH THE LATEST-GENERATION FLEXNAV DELIVERY SYSTEM ARE CONSISTENT WITH contemporary TAVI VALVES1,2
PORTICO™ WITH FLEXNAV™1
(N = 111)**
All-Cause Mortality (%)
Disabling Stroke (%)
Life-Threatening Bleeding (%)
Acute Kidney Injury Stage III (%)
Major Vascular Complications (%)
New Permanent Pacemaker (%)
Mean Gradient (mmHg)
Aortic Valve Area (cm2)
Moderate or Greater PVL (%)
† 3.3% TAVI delivery system access site-related, 1.1% non-TAVI delivery system access site-related and 0.6% non-access site-related
NOTE: Data not from head-to-head studies. Data differences depicted between these trials may not be directly comparable, statistically significant, or clinically meaningful due to differences in trial protocols, endpoints, and/or patient populations. Data provided for informational purposes only.
*Global cohort data represent a non-randomized sample of high- or extreme-risk patients that underwent an attempted Portico™ valve implant using the FlexNav™ delivery system via a transfemoral access approach between October 2018 and December 2019.
** Data represent a subset of high- or extreme-risk patients that underwent an attempted Evolut‡ R, Evolut‡ PRO or Sapien‡ 3 valve implant via a transfemoral or alternative access approach between May 2014 and October 2017. Patients were enrolled as part of a separate pivotal randomized study arm of the PORTICO IDE trial.