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Portico™ with FlexNav™ TAVI System
Clinical Performance

Outstanding TAVI
OUTCOMES

 

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

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 (%)

    3.9

    5.4

    3.4

    Acute Kidney Injury Stage III (%)

    		0.01.80.0

    Major Vascular Complications (%)

    5.0†

    7.2

    7.3

    New Permanent Pacemaker (%)

    15.4

    18.8

    5.4

    Mean Gradient (mmHg)

    7.1

    7.3

    		11.8

    Aortic Valve Area (cm2)

    1.77

    1.93

    		1.59

    Moderate or Greater PVL (%)

    4.1

    4.0

    		1.6

    † 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 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.

  • 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.
     

    SAFETY EVENT RATE (30 DAYS)

    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.

  • THE HEMODYNAMIC EDGE

     

    Consistent with other contemporary self-expanding valves, the Global FlexNav DELIVERY SYSTEM data demonstrated that Portico™ valve outperforms balloon-expanding valves, with single-digit mean gradients and larger AVAs.1,2

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

    Intra-annular Portico valve compares favorably to the supra-annular Evolut‡ R/PRO valve.
     

    SELF-EXPANDING VALVES

    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.

  • OUTPERFORMING BALLOON-EXPANDABLE VALVES1,2

    Intra-annular Portico valve offers excellent hemodynamics compared to intra-annular Sapien‡ 3 valve.
     

    OUTPERFORMING BALLOON-EXPANDABLE VALVES

    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.

  • Outcomes in Real-World Studies

    The PORTICO I Post-Market Clinical Follow-up study*, using the previous-generation delivery system, demonstrates excellent short- and long-term 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 (%)

    6.6

    6.9

    7.5

    Disabling Stroke (%)

    		2.2

    2.1

    1.1

    Mean Gradient (mmHg)

    		8.78.112.3

    AVA (cm2)

    		1.81.91.7

    New Permanent Pacemaker (%)

    		21.322.1

    15.3

    > Mild PVL (%)

    		2.61.2

    2.7

     

    *The Portico I study was conducted via transfemoral access.

Deliverability Redefined.
TAVI Reimagined.
Experience Remarkable
Deliverability.
Portico with FlexNav
TAVI System.

MAT-2006760 v2.0 | Item approved for Global OUS use only.

References
  1. Fontana GP, Bedogni F, Groh M, et al. Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System. JACC: Cardiovasc Inte. 2020. https://doi.org/10.1016/j.jcin.2020.06.041.
  2. Makkar RR, 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. 2020 Sep 5;396(10252):669-683.
  3. Sondergaard L, Rodés-Cabau J, Hans-Peter Linke A, et al. One-year outcomes with a self-expanding, repositionable transcatheter heart valve in severe aortic stenosis patients: PORTICO-I. J Am Coll Cardiol. 2018. Epub ahead of print. doi: 10.1016/j_jacc.2018.09.014.  
  4. Manoharan G, Van Mieghem NM, Windecker S, et al. 1-year outcomes with the Evolut R self-expanding transcatheter aortic valve. From the international FORWARD study. J Am Coll Cardiol Intv. 2018;11(22):2326-34.
  5. Wendler O, Schymik G, Treede H, et al. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve. Eur Heart J. 2017;38(36):2717-2726.

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