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STRUCTURAL INTERVENTIONS

AMPLATZER™ AMULET™ LAA OCCLUDER

Designed to treat patients with non-valvular atrial fibrillation (AFib) who are at risk of ischemic stroke, the Amplatzer Amulet LAA Occluder offers complete closure of the left atrial appendage (LAA) and immediately eliminates the need for oral anticoagulants.1


REDUCE THE RISK OF STROKE,
ELIMINATE ORAL ANTICOAGULANTS

What is LAAO?

Left atrial appendage occlusion is a minimally invasive catheter-based therapy to close the left atrial appendage. The Amplatzer Amulet LAA Occluder provides complete closure, immediately eliminating the need for OACs.

For those patients who are either contraindicated for OACs or wish to discontinue use, LAAO is a viable option to reduce their risk of stroke.

David Hildick-Smith

Reducing Stroke Risk

David Hildick-Smith, MD, Royal Sussex County Hospital, Brighton, England

“What this therapy [use of the Amplatzer Amulet LAA Occluder] does for the patient is twofold. One, it physically deals with the problem and reduces the risk of stroke very substantially. But more than that, it also offers patients a peace of mind.”

Life-long medication to reduce stroke risk is not an option for many patients. The Amplatzer Amulet LAA Occluder permanently closes this primary stroke pathway without requiring these patients to endure the challenges of Oral Anticoagulants (OACs).

Terry, Amplatzer Amulet occluder patient.

Listen to Terry, who received the Amplatzer Amulet Occluder, speak about how the procedure improved her life.

"I started feeling better immediately. I've been going ever since. Nothing keeps me down."

The Amulet occluder can be a good option1, 4-6 for patients who:

ARE AT RISK FOR DRUG INTERACTIONS

ARE CONTRAINDICATED
TO OACs

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HAVE HAD A BLEEDING EVENT

HAVE HAD A
BLEEDING EVENT

+

ARE AT HIGH RISK FOR FALLS

ARE AT HIGH
RISK FOR FALLS

+

ARE AT RISK FOR DRUG INTERACTIONS

ARE AT RISK FOR
DRUG INTERACTIONS

+

ARE UNABLE OR UNWILLING TO ADHERE TO ROUTINE MONITORING

ARE NOT ADHERING TO ROUTINE MONITORING

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  • For patients with poorly controlled or uncontrolled hypertension, oral anticoagulants are contraindicated. Amplatzer Amulet occluder is an alternative to life-long oral anticoagulants that are not a safe choice for these patients.

    Regina (AGE 55)

    Regina (AGE 55)

    Regina, who has NVAF and a CHA2DS2-VASc score is 4, has had poorly controlled hypertension for 10 years. Her doctor wants to reduce her stroke risk without jeopardizing her safety.

    NVAF patients with poorly controlled hypertension should know that there is an alternative.

  • The long-term bleeding risks associated with OACs such as warfarin are particularly concerning for patients with active lifestyles or occupations. Consider Amplatzer Amulet occluder for active patients.

    Rita (AGE 65)

    Rita (AGE 65)

    Rita has NVAF and a CHA2DS2-VASc score of 4. She is reducing her stroke risk without having to limit her travel and play with her grandchildren. 

    NVAF patients who want to remain active should know that there is an alternative.

  • A fall can erode a patient’s confidence and willingness to engage in everyday tasks. It can also lead to a major bleeding event. Consider Amplatzer Amulet occluder when you or your patients are concerned about the risk of falls or bleeding.

    Nathan (AGE 80)

    Nathan (AGE 80)

    Nathan, who has NVAF and a CHA2DS2-VASc score of 5, hit his head the last time he fell. He and his doctor want to reduce his stroke risk without increasing his risk for a major bleeding event.

    NVAF patients at high risk for bleeding should know that there is an alternative.
     

  • OACs are incompatible with treatments for many comorbidities including depression or arthritis. Amplatzer Amulet occluder is an alternative to oral anticoagulants that can increase the risk of drug interactions.

    Michael (AGE 75)

    Michael (AGE 75)

    Michael has Non-Valvular Atrial Fibrillation (NVAF) and a CHA2DS2-VASc score of 5. He is reducing his stroke risk without increasing his risk for drug interactions.

    NVAF patients with comorbidities should know that there is an alternative.

  • Adverse effects, the cost of Novel Oral Anticoagulants (NOACs), or the monitoring required when taking warfarin, often make compliance a challenge for patients. Amplatzer Amulet occluder is an alternative to life-long oral anticoagulants that can lead to noncompliance.

    Sarah (AGE 73)

    Sarah (AGE 73)

    Sarah has NVAF and a CHA2DS2-VASc score of 4. She is reducing her stroke risk without having to take OACs for the rest of her life.

    NVAF patients who struggle with compliance should know that there is an alternative.
     

<figure class="image"> <picture> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Medications.png" media="(max-width: 420px)"> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Medications.png" media="(max-width: 600px)">ARE AT RISK FOR DRUG INTERACTIONS </picture> </figure>

ARE CONTRAINDICATED
TO OACs

+

  • For patients with poorly controlled or uncontrolled hypertension, oral anticoagulants are contraindicated. Amplatzer Amulet occluder is an alternative to life-long oral anticoagulants that are not a safe choice for these patients.

    Regina (AGE 55)

    Regina (AGE 55)

    Regina, who has NVAF and a CHA2DS2-VASc score is 4, has had poorly controlled hypertension for 10 years. Her doctor wants to reduce her stroke risk without jeopardizing her safety.

    NVAF patients with poorly controlled hypertension should know that there is an alternative.

<figure class="image"> <picture> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Blood_Droplet.png" media="(max-width: 420px)"> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Blood_Droplet.png" media="(max-width: 600px)">HAVE HAD A BLEEDING EVENT </picture> </figure>

HAVE HAD A
BLEEDING EVENT

+

  • The long-term bleeding risks associated with OACs such as warfarin are particularly concerning for patients with active lifestyles or occupations. Consider Amplatzer Amulet occluder for active patients.

    Rita (AGE 65)

    Rita (AGE 65)

    Rita has NVAF and a CHA2DS2-VASc score of 4. She is reducing her stroke risk without having to limit her travel and play with her grandchildren. 

    NVAF patients who want to remain active should know that there is an alternative.

<figure class="image"> <picture> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/ABB_SHS_Web_icon_falls_alternative_new.svg" media="(max-width: 420px)"> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Fall.png" media="(max-width: 600px)">ARE AT HIGH RISK FOR FALLS </picture> </figure>

ARE AT HIGH
RISK FOR FALLS

+

  • A fall can erode a patient’s confidence and willingness to engage in everyday tasks. It can also lead to a major bleeding event. Consider Amplatzer Amulet occluder when you or your patients are concerned about the risk of falls or bleeding.

    Nathan (AGE 80)

    Nathan (AGE 80)

    Nathan, who has NVAF and a CHA2DS2-VASc score of 5, hit his head the last time he fell. He and his doctor want to reduce his stroke risk without increasing his risk for a major bleeding event.

    NVAF patients at high risk for bleeding should know that there is an alternative.
     

<figure class="image"> <picture> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Not_All_MHTs_Are_The_Same.png" media="(max-width: 420px)"> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Not_All_MHTs_Are_The_Same.png" media="(max-width: 600px)">ARE AT RISK FOR DRUG INTERACTIONS </picture> </figure>

ARE AT RISK FOR
DRUG INTERACTIONS

+

  • OACs are incompatible with treatments for many comorbidities including depression or arthritis. Amplatzer Amulet occluder is an alternative to oral anticoagulants that can increase the risk of drug interactions.

    Michael (AGE 75)

    Michael (AGE 75)

    Michael has Non-Valvular Atrial Fibrillation (NVAF) and a CHA2DS2-VASc score of 5. He is reducing his stroke risk without increasing his risk for drug interactions.

    NVAF patients with comorbidities should know that there is an alternative.

<figure class="image"> <picture> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Health_Monitor.png" media="(max-width: 420px)"> <source srcset="/int/fileadmin/content/Solutions-Products/LAA/Icon_Health_Monitor.png" media="(max-width: 600px)">ARE UNABLE OR UNWILLING TO ADHERE TO ROUTINE MONITORING </picture> </figure>

ARE NOT ADHERING TO ROUTINE MONITORING

+

  • Adverse effects, the cost of Novel Oral Anticoagulants (NOACs), or the monitoring required when taking warfarin, often make compliance a challenge for patients. Amplatzer Amulet occluder is an alternative to life-long oral anticoagulants that can lead to noncompliance.

    Sarah (AGE 73)

    Sarah (AGE 73)

    Sarah has NVAF and a CHA2DS2-VASc score of 4. She is reducing her stroke risk without having to take OACs for the rest of her life.

    NVAF patients who struggle with compliance should know that there is an alternative.
     

For educational purposes only; not real patient cases.

Innovative Dual Seal Technology

The Amulet occluder's innovative dual seal technology leverages a proven Amplatzer design that has been
trusted for over 20 years.2

LAA Occluder
1
The lobe, made of nitinol braiding, requires minimal depth and conforms to different LAA shapes
2
The disc delivers a complete ostial seal to create a second mechanism of closure and minimize the risk of device-related thrombus.
3
The waist provides flexibility to accommodate all morphologies.

Widest range of sizes ensure best LAA fit

The Amulet occluder offers 8 sizes and allows versatility to treat a broad range of LAA morphologies.

Amplatzer Amulet Occluder features a diverse range of sizes for unique LAA anatomies

Treating the simplest to most complex morphologies  

80%

of appendages have
more than 1 lobe10
 

NEARLY
50%
of appendages are chicken wing
anatomy which presents challenges
with a shallow landing zone11

Physician Education

Hear from physicians how the Amplatzer Amulet occluder can benefit physicians and help patients live longer, fuller lives.

VIEW All Webinars

Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use


GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

App Store
Google Play
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WATCH THE LATEST VIDEOS FROM THE GLOBAL LAAO SUMMIT

MAT-2008374 v7.0 | Item approved for OUS use only.

References
  1. Lakkireddy D, Thaler D, Ellis CR, Swarup V, Sondergaard L, Carroll J, Gold MR, Hermiller J, Diener HC, Schmidt B, MacDonald L, Mansour M, Maini B, O’Brien L, Windecker S. 2021. Amplatzer Amulet left atrial appendage occluder versus Watchman device for stroke prophylaxis (Amulet IDE): A randomized, controlled trial. Circulation, 144(19), 1543-1552
  2. Charate R, Ahmed A, Della Rocca DG, Bloom S, Garg J, Pothineni NV, DiBiase L, Turagam M, Gopinathannair R, Horton R, Kar S, Fontana G, Doshi SK, Swarup V, Finn A, Reddy V, Natale A, Lakkireddy D. 2022. Evaluation of multimodality LAA leak closure methods following incomplete occlusion: The LAA leak study. JACC Cardiovasc Interv, 15(21), 2158-2170
  3. Piayda K, Sievert K, Della Rocca D, Adeola O, Alkhouli M, Yoo D, Benito-Gonzalez T, Cruz-Gonzalez I, Galea R, Skurk C, De Backer O, Nielsen-Kudsk JE, Grygier M, Beaty E, Newton J, Perez de Prado A, Raber L, Gibson D, Van Niekerk C, Ellis CR, Horton R, Natale A, Gundwald I, Zeus T, Sievert H. 2021. Safety and feasibility of peri-device leakage closure after LAAO: An international, multi-center collaborative study. EuroIntervention, 17(12), e1033-31040
  4. Suradi HS, Hijazi ZM. 2017. Left atrial appendage closure: Outcomes and challenges. Netherlands Heart Journal, 25(2), 143-151
  5. Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GYH, Mantovani LG, Turpie AGG, van Eickels M, Misselwitz F, Rushton-Smith, S, Kayani G, Wilkinson P, Verheugt FWA. 2013. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: Perspectives from the international, observational, prospective GARFIELD registry. PLoS One, 8(5), e63479
  6. Baman JR, Mansour M, Heist EK, Huang DT, Biton Y. 2018. Percutaneous left atrial appendage occlusion in the prevention of stroke in atrial fibrillation: A systematic review. Heart Failure Reviews, 23(2), 191-208
  7. Data on File.
  8. Hildick-Smith D, Landmesser U, Camm AJ, Diener HC, Paul V, Schmidt B, Settergren M, Teiger E, Nielsen-Kudsk JE, Tondo C. 2020. Left atrial appendage occlusion with the Amplatzer Amulet device: Full results of the prospective global observational study. European Heart Journal, 41(30), 2894-2901
  9. Lakkireddy D, Thaler D, Ellis CR, Swarup V, Gambhir A, Hermiller J, Nielsen-Kudsk JE, Worthley S, Nair D, Schmidt B, Horton R, Gupta N, Anderson JA, Gage R, Alkhouli M, Windecker S. 2023. 3-Year outcomes from the Amplatzer Amulet left atrial appendage occluder randomized controlled trial (Amulet IDE). JACC Cardiovascular Interventions, 16(15), 1902-1913
  10. Veinot JP, Harrity PJ, Gentile F, Khandheria BK, Bailey KR, Eickholt JT, Seward JB, Tajik AJ, Edwards WD. 1997. Anatomy of the normal left atrial appendage: A quantitative study of age-related changes in 500 autopsy hearts: Implications for echocardiographic examination. Circulation, 96(9), 3112-3115
  11. Beigel R, Wunderlich NC, Ho SY, Arsanjani R, Siegel RJ. 2014. The left atrial appendage: Anatomy, function and noninvasive evaluation. JACC Cardiovascular Imaging, 7(12), 1251-1265
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