+
STRUCTURAL INTERVENTIONS

AMPLATZER™ AMULET™ LAA OCCLUDER

Designed to treat patients with non-valvular atrial fibrillation (AF) 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?

The Amplatzer Amulet LAA Occluder procedure is a minimally invasive catheter-based therapy to close the left atrial appendage. In AF patients, who are at a 5x greater risk of stroke, the Amulet LAA occluder provides complete closure of the left atrial appendage and immediately eliminates the need for OACs.

For those patients who are either contraindicated for OACs or wish to discontinue use, LAAO with Amulet 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).  The Amulet occluder can be a good option1, 3-6 for patients who:

ARE AT RISK FOR DRUG INTERACTIONS

CONTRAINDICTION
TO OACs

+

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

+

  • 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.
     

ARE AT RISK FOR DRUG INTERACTIONS

CONTRAINDICTION
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.

HAVE HAD A BLEEDING EVENT

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.

ARE AT HIGH RISK FOR FALLS

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.
     

ARE AT RISK FOR DRUG INTERACTIONS

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.

ARE UNABLE OR UNWILLING TO ADHERE TO ROUTINE MONITORING

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
helping patients for over 20 years.2

LAA Occluder
1
The lobe is designed to conform to different LAA anatomies including the hard to treat Chicken wing and double lobe due to its proximal placement
2
The disc completely seals the LAA orifice creating a smooth surface to minimize the risk of DRT
3
Stabilizing wires secure the device in position to prevent embolization.

More Sizes For More Anatomies

The Amulet occluder offers the most sizes to ensure a precise fit across LAA anatomies.

Amplatzer Amulet Occluder features a diverse range of sizes for unique LAA anatomies
Amplatzer Amulet LAA Occluder offers 8 device sizes

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.

Show nearest:
Filter by:

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

NEW VERSION AVAILABLE
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

MAT-2111179 v8.0 | Item approved for U.S. use only.

+
Stay Informed
References
  1. Amplatzer Amulet LAA Occluder Instructions for Use.
  2. Data on file at Abbott.
  3. Lakkireddy D, Thaler D, Ellis CR, et al. Amplatzer™ Amulet™ Left Atrial Appendage Occluder versus Watchman™ device for stroke prophylaxis (Amulet IDE): A randomized controlled trial. Circulation. 2021; doi.org/10.1161/CIRCULATIONAHA.121.057063.
  4. Suradi HS, et al. Left atrial appendage closure: outcomes and challenges. Neth Heart J. 2017;25:143-151. doi: 10.1007/s12471-016-0929-0.
  5. Kakkar AK, et al. 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. doi.org/10.1371/journal.pone.0063479.
  6. Baman JR, et al. Percutaneous left atrial appendage occlusion in the prevention of stroke in atrial fibrillation: a systematic review. Heart Failure Rev. 2018;23:191-208. doi.org/10.1007/s10741-018-9681-4.
Important Safety Information

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.

Find a Clinic

Find a Clinic

Follow Abbott

Copyright © 2023 Abbott, 3200 Lakeside Dr, Santa Clara, 95054, 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-2004021 v23.0  |   Item approved for U.S. use only.

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.

U.S. VISITOR INTERNATIONAL VISITOR

YOU ARE ABOUT TO LEAVE
www.structural­heart.abbott

You are now leaving www.structuralheart.abbott. 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
+