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

LAAO Overview

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 option1-5 for patients who:

CONTRAINDICTION
TO OACs

HAVE HAD A
BLEEDING EVENT

ARE AT HIGH
RISK FOR FALLS

ARE AT RISK FOR
DRUG INTERACTIONS

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, 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 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, 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 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 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.
     

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, 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

  • 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 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

  • 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, 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

  • 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 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 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 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.1

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.

Controlled and precise placement with the first and only U.S. approved steerable sheath

Designed for the Amulet occluder, the Amplatzer steerable delivery sheath features:

  • Bi-directional steering for coaxial alignment in the LAA
  • An integrated hemostasis valve to minimize blood loss
  • A braided shaft to prevent kinking
  • Auto-lock to maintain the desired position




Amplatzer™ Steerable Delivery Sheath

  • One sheath fits all Amplatzer Amulet occluder sizes
  • Can be used in a range of anatomies – from simple to challenging
  • Two-way deflection ranges form 0° to 120°

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