AbbottAbbott
INT

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.

GET CLINICAL INSIGHTS

DOWNLOAD

PATIENT EDUCATION

READ MORE

Let’s get in touch!

Contact us

Copyright © 2021 Abbott. Abbott Park, Illinois, U.S.A.
Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

MAT-2000631 v5.0 | Item approved for Global OUS use only.

Download

Safety Profile Clinical Insights

get report

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.

International Health Care Professionals U.S. Health Care Professionals

YOU ARE ABOUT TO LEAVE
www.structural­heart­solutions.com

You are now leaving www.structuralheartsolutions.com. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.

OkCancel