TAVI

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. 

ADVANCED OUTCOMES WITH THE
PORTICO WITH FLEXNAV TAVI SYSTEM*1

KM RATE AT 30 DAYS

0.6%

ALL-CAUSE
MORTALITY

1.1%

DISABLING
STROKE

3.9%

LIFE-THREATENING
BLEEDING

0.0%

ACUTE KIDNEY INJURY
STAGE III

5.0

MAJOR VASCULAR
COMPLICATIONS

3.3% TAVI delivery system access site-related, 1.1% non-TAVI delivery system access site-related and 0.6% non-access site-related
*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.

  • CLINICAL OUTCOMES IN CONTEXT

    OUTCOMES WITH THE LATEST-GENERATION FLEXNAV DELIVERY SYSTEM ARE CONSISTENT WITH CONTEMPORARY TAVI VALVES1,2 

     30-DAY COMPARISON
     PORTICO™ WITH FLEXNAV™1
    (N = 180)*
    EVOLUT R/PRO2
    (N = 111)**
    SAPIEN 32
    (N = 206)**
    All-Cause Mortality (%)0.61.80.0
    Disabling Stroke (%)1.10.91.0
    Life-Threatening Bleeding (%)3.95.43.4
    Acute Kidney Injury Stage III (%)0.01.80.0
    Major Vascular Complications (%)5.07.27.3
    New Permanent Pacemaker (%)15.418.85.4
    Mean Gradient (mmHg)7.17.311.8
    Aortic Valve Area (cm2)1.771.931.59
    Moderate or Greater PVL (%)4.14.01.6

    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 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 Sapien3 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.

  • SAFETY EVENT RATE (30 DAYS)

    COMPOSITE OF ALL-CAUSE MORTALITY, DISABLING STROKE, LIFE-THREATENING BLEEDING REQUIRING TRANSFUSION, ACUTE KIDNEY INJURY REQUIRING DIALYSIS, OR MAJOR VASCULAR COMPLICATIONS

     

    NOTE: Data not from head-to-head studies. 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.

  • SELF-EXPANDING VALVES. SINGLE-DIGIT GRADIENTS.1,2

    INTRA-ANNULAR PORTICO VALVE COMPARES FAVORABLY TO THE SUPRA-ANNULAR EVOLUT R/PRO VALVE.

     

    NOTE: Data not from head-to-head studies. 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.

  • THE HEMODYNAMIC EDGE


     

    CONSISTENT WITH OTHER CONTEMPORARY SELF-EXPANDING VALVES, THE GLOBAL FLEXNAV COHORT (N=180) DATA DEMONSTRATED THAT THE PORTICO™ VALVE OUTPERFORMS BALLOON-EXPANDING VALVES, WITH SINGLE-DIGIT MEAN GRADIENTS AND LARGER AVAS.1,2

  • OUTPERFORMING BALLOON-EXPANDABLE VALVES1,2

    INTRA-ANNULAR PORTICO VALVE OFFERS EXCELLENT HEMODYNAMICS COMPARED TO INTRA-ANNULAR SAPIEN 3 VALVE.

     

    NOTE: Data not from head-to-head studies. 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.

  • OUTCOMES IN REAL-WORLD STUDIES

    THE PORTICO I POST-MARKET CLINICAL FOLLOW-UP STUDY, USING THE PREVIOUS-GENERATION DELIVERY SYSTEM, DEMONSTRATES EXCELLENT CLINICAL OUTCOMES ACROSS A BROAD IMPLANTER BASE, INCLUDING LOW RATES OF PVL, CONSISTENT WITH OTHER CONTEMPORARY TAVI VALVES.3-5

     1-YEAR COMPARISON**
     

    PORTICO I3

    PORTICO™

    (N = 941)*

    FORWARD4

    EVOLUT R

    (N = 1040)**

    SOURCE 35

    SAPIEN 3

    (N = 1694)**

    All-Cause Mortality (%)12.18.911.8
    Cardiac Mortality (%)6.66.97.5
    Disabling Stroke (%)2.22.11.1
    Mean Gradient (mmHg)8.88.112.3
    AVA (cm2)1.71.91.7
    New Permanent Pacemaker (%)21.322.115.3
    > Mild PVL (%)2.61.22.7

    NOTE: Data not from head-to-head studies. 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 EvolutR, 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 Portico I study was conducted via transfemoral access.
    No severe PVL was observed.

MAT-2006760 v3.0 | Item approved for Global OUS use only.

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