PORTICO™ WITH FLEXNAV™ TAVI SYSTEM CLINICAL DATA
The Portico™ with FlexNav™ Transcatheter Aortic Valve Implantation (TAVI) System features an exceptional design that was purposefully built to give you complete, independent control of valve delivery while offering remarkable flexibility and exceptionally smooth tracking.
OUTCOMES WITH THE
PORTICO WITH FLEXNAV TAVI SYSTEM*1
30 Day and 1 Year Clinical Outcomes
Global Portico with Flexnav Cohort
(N=193)
KM Rates | 30 DAYS | 1 YEAR |
---|---|---|
All-Cause Mortality (%) | 1.0 | 4.7† |
Disabling Stroke (%) | 2.1 | 2.1 |
Mean Gradient†† (mmHg) | 7.1 | 7.4 |
Aortic Valve Area†† (cm2) | 1.8 | 1.76 |
Moderate or Greater PVL†† (%) | 2.8 | 0.6** |
†Rate censoring COVID-19 related death.
††Data presented for subjects that received 1 or more of the treatment assigned valve: Portico with FlexNav Cohort: n=191
*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.
**All five subjects who had moderate PVL at 30 days were alive and completed echo assessments at 1 year and only one of the five subjects remained Moderate; three subjects improved to Mild and one subject improved to None/Trace at 1 year.
- CLINICAL OUTCOMES IN CONTEXT
OUTCOMES WITH THE LATEST-GENERATION FLEXNAV DELIVERY SYSTEM ARE CONSISTENT WITH CONTEMPORARY TAVI VALVES1
30-DAY RESULTS
PORTICO RCT GLOBAL FLEXNAV COHORT2
(N = 193)*PORTICO™ Valve RCT2
(N = 375)COMMERCIALLY AVAILABLE VALVES (CAV)2
(N = 362)All-Cause Mortality (%) 1.0 4.5 1.4 Disabling Stroke (%) 2.1 1.6 0.8 Life Threatening Requiring Blood Transfusion (%) 4.1 4.8 3.6 Acute Kidney Injury Requiring Dialysis (%) 0.0 1.1 0.8 Major Vascular Complications (%) 5.7† 9.6 6.6 New Permanent Pacemaker (%) 15.4 28.1 11.6 Moderate or Greater PVL†† (%) 2.8 6.1 2.1 †3.6% TAVI DS access site-related, 1.6% non-TAVI DS access site-related and 0.5% non-access site-related.
††Data presented for subjects that received 1 or more of the treatment assigned valve: Portico with FlexNav Cohort: n=191; Portico™ valve RCT: n=366, CAV: n=362
*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 February 2020. - SAFETY EVENT RATE (30 DAYS)2
COMPOSITE OF ALL-CAUSE MORTALITY, DISABLING STROKE, LIFE-THREATENING BLEEDING REQUIRING TRANSFUSION, ACUTE KIDNEY INJURY REQUIRING DIALYSIS, OR MAJOR VASCULAR COMPLICATIONS
*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 February 2020.
- PORTICO WITH FLEXNAV OFFERS EXCELLENT HEMODYNAMICS1††
GLOBAL PORTICO WITH FLEXNAV DELIVERY SYSTEM COHORT*1
HEMODYNAMIC VALVE PERFORMANCE (N=193)*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 February 2020.
††Data presented for subjects that received 1 or more of the treatment assigned valve: Portico with FlexNav Cohort: n=191; Portico valve RCT: n=366, Evolutⱡ R/PRO: n=110; Sapienⱡ 3: n=206 - SELF-EXPANDING VALVES. SINGLE-DIGIT GRADIENTS.3
INTRA-ANNULAR PORTICO™ VALVE COMPARES FAVORABLY TO THE SUPRA-ANNULAR EVOLUT‡ R/PRO VALVE.
NOTE: Portico aortic valve gradients and aortic valve areas compared with Evolut‡ R/PRO valves in the as-treated population.
**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.
- THE HEMODYNAMIC EDGE
CONSISTENT WITH OTHER LEADING SELF-EXPANDING VALVES, ECHO CORE LAB DATA DEMONSTRATED THAT PORTICO™ VALVE OUTPERFORMS BALLOON-EXPANDABLE VALVES, WITH SINGLE-DIGIT MEAN GRADIENTS AND LARGER AVAs.3
- OUTPERFORMING BALLOON-EXPANDABLE VALVES3
INTRA-ANNULAR PORTICO VALVE OFFERS EXCELLENT HEMODYNAMICS COMPARED TO INTRA-ANNULAR SAPIEN‡ 3 VALVE.
NOTE: Portico aortic valve gradients and aortic valve areas compared with Sapien‡ 3 valves in the as-treated population.
**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.
MAT-2200948 v3.0 | Item approved for U.S. use only.