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TAVI

PORTICO™ WITH FLEXNAV™ TAVI SYSTEM

Deliverability Redefined. A Future Optimized.

The deliverability you want.
The outcomes you expect.

Portico™ with FlexNav™ TAVI System's exceptional design was purposefully built to give you complete, independent control of valve delivery.

  • Achieve excellent outcomes without compromising delivery technique1
  • Experience a calm, controlled valve deployment, due to continuous hemodynamic stability2
  • Treat every case, even the most tortuous anatomies
  • Allow for future treatment options by preserving access to coronaries
  • Achieve a low profile with integrated sheath

Portico with FlexNav TAVI System
 

Abbott Portico with FlexNav TAVI 14F low-profile system

*14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.

Deliverability redefined. A future optimized.

Abbott Portico with FlexNav, deliverability redefined

Abbott total support

A partnership in excellence

We owe it to our communities to discover novel treatments and continuously improve our current technologies to address unmet—or undertreated—needs with improved benefit-to-risk profiles over current standard of care

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For patients with symptomatic severe aortic stenosis

Transcatheter aortic valve implantation (TAVI) provides an alternative, minimally invasive treatment option for people living with symptomatic severe aortic stenosis who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky. There are multiple factors, health conditions, indications and screenings that are utilized to determine if a patient is an eligible candidate for TAVI. The STS score allows physicians to calculate a patient’s risk of mortality and morbidities for a TAVI procedure. It is one of several sources of information in the decision-making and eligibility process. 

TAVI with the Portico™ valve can offer several key benefits. It is less invasive than open-heart surgery, with minimal scarring and a shorter hospital stay and recovery time.

Once the Portico valve has been implanted, patients may experience immediate improvement in quality of life or may feel better gradually. Improvement may include:

  • Increased physical activity
  • Increased energy
  • Decreased or no chest pain
  • Decreased or no shortness of breath
  • Decrease severity of all or most previous symptoms

For educational purposes only; not real patient cases.

  • Quality of Life and Recovery Time

    John, 84 years, male

    John had severe symptomatic aortic stenosis and an STS score of 8%. He was experiencing chronic fatigue and had limited activity due to chronic back pain. Since John lives independently, his doctor determined John is a good candidate for TAVI when considering his recovery time for TAVI vs. open heart surgery.

  • History of Cancer, Radiation and Kidney Disease

    Samuel, 73 years, male

    Samuel had severe symptomatic aortic stenosis and an STS score of 10%. He experienced symptoms of aortic stenosis after physical exertion like yard work or working in his garage. Samuel is retired and lives with his wife.  Due to his history of cancer, radiation and kidney disease, his doctors determined he’d be a good candidate for TAVI. 

  • Small Valve Annulus

    Nancy, 79 years, female

    Nancy had severe symptomatic aortic stenosis and an STS score of 8.5%. She felt shortness of breath and weak when walking her dog. She loves spending time with her grandchildren but had been feeling too tired and weak to meet with them. Given Nancy was frail, petite and had a small aortic valve her doctors determined she’d be a good candidate for TAVI in order to preserve her heart and blood pumping function. 

  • History of Coronary Artery Disease and COPD

    Carl, 75 years, male

    Carl had severe symptomatic aortic stenosis and an STS score of 8%. He experienced chest pain and shortness of breath. He has COPD, diabetes and a history of coronary artery disease so he went to his doctor right away to get checked out. His doctors determined he’d be a good candidate for TAVI given he may need additional coronary interventions (stents) in the future. 

 


Portico With FlexNav TAVI System requires 76% less insertion force than Evolut‡ PRO Valve with Enveo‡ PRO*7
 

DOWNLOAD TAVI INSERTION DATA RESULTS


*Based on insertion through a seal to simulate femoral artery.
‡Indicates a third-party trademark, which is property of its respective owner.

Abbott Portico with FlexNav TAVI requires less insertion force
Abbott Portico with FlexNav TAVI insertion test shows less force
Figure 1. The insertion test measured the force required to insert the loaded delivery systems, A) Portico with FlexNav TAVI System and B) the Evolut‡ PRO valve with EnVeo‡ PRO, through a seal.7


Portico with FlexNav TAVI system is 63% more deliverable than Evolut‡ PRO valve with Enveo‡ PRO*7

Bench tests reveal important deliverability test results. Download the Engineering Insights for a summary of the objective, methodology, and results.

DOWNLOAD DELIVERABILITY RESULTS


*Based on Abbott simulated track-force testing.
‡Indicates a third-party trademark, which is property of its respective owner.

Abbott Portico with FlexNav TAVI system deliverability test

The system that delivers

See progress as you go

Feel every advancement

Open and close with ease

EXPERIENCE THE STABILITY LAYER FOR ACCURATE PLACEMENT

Lock in placement accuracy

Dial in the details

  • A deployment indicator gives you a clear visualization of the valve’s deployment progress.

  • The simple deployment wheel provides both audible and tactile feedback as you deploy the valve.

  • Two macro-slide buttons make it easy for you to open and close the distal end of the delivery system during valve loading and post-deployment.

  • Eliminates all motion of the delivery system at the vessel access site during deployment.5,6

  • The automatic lock button prevents full valve deployment until you’ve got the valve right where you want it.

  • With the unique micro-adjustment wheel, you can close gaps between the valve capsule and the atraumatic nosecone.

FlexNav TAVI system features

See progress as you go

A deployment indicator gives you a clear visualization of the valve’s deployment progress.

Feel every advancement

The simple deployment wheel provides both audible and tactile feedback as you deploy the valve.

Open and close with ease

Two macro-slide buttons make it easy for you to open and close the distal end of the delivery system during valve loading and post-deployment.

EXPERIENCE THE STABILITY LAYER FOR ACCURATE PLACEMENT

Eliminates all motion of the delivery system at the vessel access site during deployment.5,6

Lock in placement accuracy

The automatic lock button prevents full valve deployment until you’ve got the valve right where you want it.

Dial in the details

With the unique micro-adjustment wheel, you can close gaps between the valve capsule and the atraumatic nosecone.
  • Deliverability and deployment redefined

    Remarkable deliverability in a self-expanding platform.

    Portico with FlexNav TAVI System brings together innovation across every aspect of its design, offering remarkable flexibility and exceptionally smooth tracking.

    3D Flexibility. Infinite possibility.

    FlexNav offers three-dimensional flexibility at the distal end and throughout its entire working length.

    Atraumatic nosecone

    Large-Cell framework

    Flexible capsule

    Hydrophilic coating

    Integrated sheath

    • Atraumatic nosecone and smooth transitions are designed to reduce risk of vascular complications and calcium dislodgement.

    • The large-cell framework of the Portico™ valve reduces metal mass, resulting in a more flexible capsule.

    • The capsule is more flexible because it does not require bilateral metal rails or extra nitinol braiding, resulting in enhanced flexibility.7

    • Hydrophilic coating reduces friction by 98%,7 providing lubricity to guide the system through vasculature.

    • Integrated sheath for low 14 F delivery profile.3*
      * 14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.

    FlexNav TAVI system offers 3D flexibility
    1
    2
    3
    4
    5
    1. Atraumatic nosecone and smooth transitions are designed to reduce risk of vascular complications and calcium dislodgement.
    2. The large-cell framework of the Portico™ valve reduces metal mass, resulting in a more flexible capsule.
    3. The capsule is more flexible because it does not require bilateral metal rails or extra nitinol braiding, resulting in enhanced flexibility.7
    4. Hydrophilic coating reduces friction by 98%,7 providing lubricity to guide the system through vasculature.
    5. Integrated sheath for low 14 F delivery profile.3*

    * 14 F equivalent integrated sheath diameter for patients requiring 23 mm or 25 mm valve.

  • Feedback from Portico with FlexNav TAVI system users*

    OVERALL DELIVERABILITY

    “There’s not another valve out there that allows you to have such a relaxing delivery.”

    Interventional Cardiologist, United States of America

    OVERALL FLEXIBILITY

    “The system is a major advancement. With release, it didn’t move at all. And this was in a relatively horizontal aorta. We were able to end up being three mm in both the non-coronary and the left coronary side. Perfect implant. Very impressed. Big improvement.”

    Interventional Cardiologist, United States of America

    PLACEMENT ACCURACY

    “A key element of this is the stability of the delivery. Having done a lot of cases before, I and the team had a really good understanding of the movements of the valve when it was being released or retracted. But here, with the FlexNav System, it is just stable throughout the whole delivery.”

    Interventional Cardiologist, Australia

    EXCELLENT HEMODYNAMICS

    “Portico has best-in-class hemodynamics. It busts the myth that supra-annular leaflet design is needed to optimize hemodynamics.”

    Interventional Cardiologist, United States of America

    *These testimonials do not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual's experience and might not be representative of others. 

DOWNLOAD 

TAVI Insertion Data Results
 

GET REPORT


Thinking Ahead

Large-cell geometry and intra-annular valve position preserve coronary access.

Abbott Portico valve features large-cell geometry and intra-annular valve position



ON TARGET, EVERY TIME

Every aspect of Portico with FlexNav was designed to help you place the valve on target, every time. But in case you need to make a move, rest assured.

Abbott Portico with FlexNav TAVI system is recapturable, repositionable, and retrievable




RECAPTURABLE*

REPOSITIONABLE*

RETRIEVABLE*

*Until fully deployed.
 

Stable from the start

Continuous hemodynamic stability, no rapid pacing

Intra-annular leaflet position in a self-expanding valve provides early valve function and hemodynamic stability throughout the procedure—for calm and controlled deployment, without compromise.

Abbott Portico with FlexNav TAVI system offers stable deployment


Portico with FlexNav TAVI system

Portfolio of Portico valve sizes

There are 4 sizes of the Portico valve—23, 25, 27, and 29 mm—covering an annulus range of 19-27 mm.

There are 4 sizes of the the Abbott Portico valve
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Download TAVI Insertion Data Results

 MAT-2106521 v6.0 Item approved for U.S. use only.

References
  1. 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;396:669-683.
  2. Agnifili M, Brambilla N, Testa L, et al. Use of the SoloPath re-collapsible balloon access system for troublesome femoral access with the Portico transcatheter valve. Radcliffe Cardiology. June 2015.
  3. Portico Instructions for Use.
  4. Möllmann H, Linke A, Holzhey DM, et al. Implantation and 30-day follow-up on all 4 valve sizes within the Portico transcatheter aortic bioprosthetic family. JACC Cardiovasc Interv. 2017;10:1538-1547.
  5. Supplement to Cardiac Interventions Today Europe. vol 4(1) 2020.
  6. 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 Interv. 2020;13:2467-2478.
  7. Data on file at Abbott.
Important Safety Information

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.

WARNINGS

Carefully read all warnings, precautions, and instructions for use for all components of the system before use. Failure to read and follow all instructions or failure to observe all stated warnings could cause serious injury or death to the patient.

  • Perform Portico™ valve implantation in a facility where emergency aortic valve surgery is available.
  • Verify that the patient’s anatomy is consistent with the specifications set forth in the anatomical specifications tables 2 and 3 (found in IFU).
  • For single use only. Do not reuse, reprocess, or resterilize the valve, delivery system, or the loading system. Reuse, reprocessing, and/or resterilization creates a risk of contamination of the devices and/or device failure, which could cause patient injury, illness or death.
  • Do not manipulate or handle the valve with sharp or pointed objects.
  • Rinse the valve as directed before loading the valve onto the delivery system.
  • Do not use the valve, the delivery system, or the loading system if the “USE BY” date has elapsed.
  • Exercise care to prevent kinking of the delivery system when removing it from the packaging.
  • This device contains nitinol, an alloy of nickel and titanium. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials.
  • Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, young adults, or patients with altered calcium metabolism.

PRECAUTIONS

Pre-Implantation Precautions

  • The safety, effectiveness, and durability of a Portico™ valve implanted within a surgical or transcatheter bioprosthesis have not been demonstrated.
  • Long-term durability has not been established for the Portico valve. Regular medical follow-up is advised to evaluate valve performance.
  • For transaortic access, ensure the access site and trajectory are free of internal patent right internal mammary artery (RIMA) or pre-existing patent RIMA graft.
  • For subclavian/axillary access, use caution in patients with mammary artery grafts.
  • Balloon aortic valvuloplasty (BAV) of the native aortic valve is recommended prior to delivery system insertion. The balloon size chosen should be appropriate, not exceeding the minimum diameter of the native aortic annulus as assessed by CT imaging to minimize risk of annular rupture and not undersized to minimize risk of stent under-expansion which could lead to paravalvular leak (PVL) or device migration.
  • Do not use the valve if the shipping temperature indicator on the product package has turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
  • Do not use the valve if the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
  • Do not advance the delivery system without the guidewire extending from the tip.
  • Do not use the valve without thoroughly rinsing as directed.
  • Do not use the delivery system without thoroughly flushing as described in the "Directions for Use" section.
  • The safety and effectiveness of the Portico™ valve and FlexNav™ delivery system have not been evaluated in the following patient populations:
    • Congenital unicuspid or bicuspid valve, or any leaflet configuration other than tricuspid
    • Severe ventricular dysfunction with left ventricular ejection fraction <20%
    • Non-calcific aortic annulus
    • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
    • Patients at low or intermediate surgical risk
    • Patients who are pregnant or breastfeeding
    • Pediatric patients (less than 21 years of age)
    • Patients with a pre-existing prosthetic heart valve or prosthetic ring in any position
    • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
    • Patients with severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise
    • Blood dyscrasias as defined: leukopenia (WBC<3000 mm³), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³)
    • Patients with untreated clinically significant coronary artery disease requiring revascularization
    • Patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia
    • Hypertrophic cardiomyopathy with or without obstruction (HOCM)
    • Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis
    • Hemodynamic instability requiring inotropic support or mechanical heart assistance
    • Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta
    • Patients with known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated
    • Patients with access characteristics that would preclude safe placement of the introducer sheath, when necessary, such as severe obstructive calcification, or severe tortuosity

Implantation Precautions

  • To minimize risk of guidewire perforations in the left ventricle, a manufacturer pre-shaped guidewire should be used during the procedure and during valve deployment.
  • Do not deploy the valve if excessive resistance to deployment is encountered. If the valve does not deploy easily, re-sheath the valve, remove it from the patient, and use a different valve and delivery system.
  • Follow the procedure in “Implanting the Valve” to reposition the valve or to remove the valve from the patient.
  • Do not attempt to reposition the valve by advancing it distally unless the valve has been fully re-sheathed within the delivery system.
  • Do not re-sheath the valve more than two times prior to final valve release. Additional re-sheath attempts may compromise product performance.
  • To minimize likelihood of permanent pacemaker implantation (PPI): a) maintain implant depth of 3mm, and b) limit manipulations across the LVOT.

Post-Implantation Precautions

  • In the event that a post-implant balloon dilatation is performed to address paravalvular leak (PVL), valve size, patient anatomy, and implant depth must be considered when selecting the size of the balloon for dilatation. The balloon size chosen should not exceed the mean diameter of the native aortic annulus. Moderate or Severe PVL should be addressed at the time of the TAVI procedure.
  • Exercise care when removing the delivery system from the patient.
  • Exercise care when crossing the valve with adjunctive devices.
  • Once the valve is fully deployed, repositioning and retrieval of the valve is not possible. Attempted retrieval (e.g., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.
  • Valve recipients should be maintained on antiplatelet and/or anticoagulant therapy post procedure, per institutional standards and established guidelines, except when contraindicated, using individualized treatment as determined by their physician.
  • Post-implant monitoring and/or possible electrophysiology evaluation may be considered in patients with transient high degree or complete AV block or other conduction disturbances during or following implantation of the valve. This may include continuous ECG monitoring after hospital discharge.

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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