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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

30 Day and 1 Year Clinical Outcomes

Global Portico with FlexNav Cohort
(N=193)

KM Rates30 DAYS1 YEAR
All-Cause Mortality (%)1.04.7†
Disabling Stroke (%)2.12.1
Mean Gradient†† (mmHg)7.17.4
Aortic Valve Area†† (cm2)1.781.76
Moderate PVL†† (%)2.80.6**

†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 COMPARISON

     PORTICO WITH FLEXNAV1,2
    (N = 193)*    		PORTICO™ Valve RCT3
    (N = 375)    		EVOLUT‡ R/PRO3
    (N = 111)**    		SAPIEN‡33 
    (N = 206)**
    All-Cause Mortality (%)1.04.51.80.0
    Disabling Stroke (%)2.11.60.91.0
    Life-Threatening Bleeding (%)4.16.45.43.4
    Acute Kidney Injury Stage III (%)0.01.91.80.0
    Major Vascular Complications (%)5.7†9.67.27.3
    New Permanent Pacemaker (%)15.428.118.85.4
    Mean Gradient†† (mmHg)7.18.47.311.8
    Aortic Valve Area†† (cm2)1.781.851.931.59
    Moderate or Greater PVL†† (%)2.86.34.01.6

    NOTE: Data not from head-to-head studies. Data provided for informational purposes only.

    †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, Evolutⱡ R/PRO: n=110; Sapienⱡ 3: n=206
    *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 represent a subset of high- or extreme-risk patients that underwent an attempted Evolutⱡ 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.

  • 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 February 2020.
    **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.

  • 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: Data not from head-to-head studies. Data provided for informational purposes only.

    **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: Data not from head-to-head studies. Data provided for informational purposes only.

    **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-2006760 v5.0 | Item approved for OUS use only.

References

‡ Indicates a third-party trademark, which is property of its respective owner.

  1. Makkar R. One-year outcomes for an intra-annular self-expanding transcatheter aortic valve and next-generation low-profile delivery system. Presented at CRT 2022, Washington D.C.
  2. Portico IFU.
  3. Makkar R, Cheng W, Waksman R, et al. Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial. Lancet Published Online June 25, 2020. Supplemental Appendix (Table S7) doi.org/10.1016/S0140-6736(20)31358-1.
  4. Abbott data on file CL1016596.
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