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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. 

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)1.81.76
Moderate or Greater 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 RESULTS

      PORTICO RCT
     GLOBAL FLEXNAV COHORT2
    (N = 193)*    		PORTICO™ Valve RCT2
    (N = 375)    		COMMERCIALLY AVAILABLE VALVES (CAV)2
    (N = 362)
    All-Cause Mortality (%)1.04.51.4
    Disabling Stroke (%)2.11.60.8
    Life Threatening Requiring Blood Transfusion (%)4.14.83.6
    Acute Kidney Injury Requiring Dialysis (%)0.01.10.8
    Major Vascular Complications (%)5.7†9.66.6
    New Permanent Pacemaker (%)15.428.111.6
    Moderate or Greater PVL†† (%)2.86.12.1

    †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.

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 RR, 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.
Important Safety Information

Rx Only

PORTICO™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

INDICATIONS

The Portico™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

CONTRAINDICATIONS

The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

POTENTIAL ADVERSE EVENTS

Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explantation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.

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