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STRUCTURAL INTERVENTIONS

Amplatzer™ Amulet™
Left Atrial Appendage 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

CLOSURE. ONCE AND FOR ALL.2,3

The Amplatzer Amulet LAA Occluder offers a dual seal design to treat virtually all morphologies and provide closure, once and for all.

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

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:

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

ARE CONTRAINDICATED TO
TO OACs

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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.

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

HAVE HAD A
BLEEDING EVENT

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  • The long-term bleeding risks associated with OACs, such as Warfarin are particularly concerning for patients with active lifestyles or occupations. Amplatzer Amulet Occluder supports the freedom to have a more active lifestyle.

    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="/fileadmin/content/Solutions-Products/LAA/Icon_Fall.png" media="(max-width: 420px)"> <source srcset="/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

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  • 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="/fileadmin/content/Solutions-Products/LAA/Icon_Not_All_MHTs_Are_The_Same.png" media="(max-width: 420px)"> <source srcset="/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

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  • 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="/fileadmin/content/Solutions-Products/LAA/Icon_Health_Monitor.png" media="(max-width: 420px)"> <source srcset="/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

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  • Adverse effects, cost and monitoring can make compliance a challenge for patients. Amplatzer Amulet occluder is an alternative to life-long oral anticoagulants. 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="/fileadmin/content/Solutions-Products/LAA/Icon_Not_All_MHTs_Are_The_Same.png" media="(max-width: 420px)"> <source srcset="/fileadmin/content/Solutions-Products/LAA/Icon_Medications.png" media="(max-width: 600px)">ARE AT RISK FOR DRUG INTERACTIONS </picture> </figure>

ARE CONTRAINDICATED
TO OACs

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

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<figure class="image"> <picture> <source srcset="/fileadmin/content/Solutions-Products/LAA/Icon_Fall.png" media="(max-width: 420px)"> <source srcset="/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

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<figure class="image"> <picture> <source srcset="/fileadmin/content/Solutions-Products/LAA/Icon_Not_All_MHTs_Are_The_Same.png" media="(max-width: 420px)"> <source srcset="/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

+

<figure class="image"> <picture> <source srcset="/fileadmin/content/Solutions-Products/LAA/Icon_Health_Monitor.png" media="(max-width: 420px)"> <source srcset="/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

+

  • 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. Amplatzer Amulet Occluder supports the freedom to have a more active lifestyle.

    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 non-vitamin K antagonist 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.

Dual Seal Technology

  • Designed to seal all morphology types7
  • Reduces the risk of stroke8
  • Eliminates the need for OACs9

The Amplatzer Amulet occluder offers two mechanisms of closure designed to ensure complete occlusion.

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

Unmatched features for precision and control.

The Amulet Steerable Delivery Sheath enables optimal placement of the Amplatzer Amulet LAA Occluder.

Find an Amplatzer Amulet LAAO
Certified Physician Near Me

Use this tool to refer a patient or consult with a certified implanting physician near you.

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

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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. 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
Important Safety Information
  • AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER
  • AMULET™ STEERABLE DELIVERY SHEATH

  • Rx Only

    AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER

    INDICATION FOR USE

    The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

    CONTRAINDICATIONS

    The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

    • With the presence of intracardiac thrombus.
    • With active endocarditis or other infections producing bacteremia.
    • Where placement of the device would interfere with any intracardiac or intravascular structures.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events associated with the device or implant procedure include, but are not limited to, the following: Air embolism; Airway trauma; Allergic reaction; Anemia; Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other); Arrhythmia; Atrial septal defect; Bleeding; Cardiac arrest; Cardiac tamponade; Chest pain/discomfort; Congestive heart failure; Death; Device embolization; Device erosion; Device malfunction; Device malposition; Device migration; Device-related thrombus; Fever; Hematuria; Hypertension/hypotension; Infection; Multi-organ failure; Myocardial infarction; Perforation; Pericardial effusion; Pleural effusion; Renal failure/dysfunction; Respiratory failure; Seizure; Significant residual flow; Stroke; Thrombocytopenia; Thromboembolism: peripheral and pulmonary; Thrombus formation; Transient ischemic attack; Valvular regurgitation/insufficiency; Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other); Vessel trauma/injury.

  • Rx Only

    AMULET™ STEERABLE DELIVERY SHEATH

    INDICATION FOR USE

    The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

    CONTRAINDICATIONS

    The Amulet™ Steerable Delivery Sheath is contraindicated for patients:

    • With the presence of thrombus that is in the pathway of the steerable sheath, including within the left atrial appendage
    • With active infections including endocarditis

    The Amulet™ Steerable Delivery Sheath is contraindicated for use with a power injection system.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that can occur during or after a procedure using this sheath may include but are not limited to: Air embolism, Allergic reaction/toxic effects (due to anesthesia, contrast media, etc.); Arrhythmia; Arteriovenous fistulae; Bleeding; Cardiac tamponade; Cardiac perforation; Death; Dissection; Embolism; Foreign material embolus; Heart failure; Hematoma; Hypotension/hypertension; Infection; Myocardial infarction/ischemia; Pericardial effusion; Peripheral embolism; Pseudoaneurysm; Stroke; Thrombosis; Transient ischemic attack; Vascular access site injury (such as arteriovenous fistulae, hematoma, pseudoaneurysm), Vessel trauma/damage.

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