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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

NOW AVAILABLE IN THE U.S.
THOUSANDS OF PATIENTS TREATED WORLDWIDE

Introducing the first and only LAA occluder that offers immediate freedom from oral anticoagulants (OACs). With unique dual seal technology to ensure immediate and complete closure and the widest range of sizes of any LAA occluder, Amplatzer™ Amulet™ makes closure an option for more patients with atrial fibrillation (AF).1,2

GET THE STUDY RESULTS: AMULET™ VS WATCHMAN‡

‡Indicates a third-party trademark, which is property of its respective owner.

Amplatzer Amulet is the first and only LAA occluder to eliminate need for oral anticoagulants

Amplatzer Amulet is the first and only FDA approved LAA occluder that offers immediate freedom from OACs. Finally, closure is an option for patients who1-5:

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 UNABLE OR UNWILLING TO ADHERE TO ROUTINE MONITORING

DUAL SEAL TECHNOLOGY TO COMPLETELY SEAL THE ORIFICE

Innovative dual seal design, leverages a proven Amplatzer design that has been trusted for over 20 years.1

First: Amplatzer Amulet Occluder conforms to different shapes of LAA anatomy and requires minimal depth for implant.

Second: DISC covers completely the LAA opening - effectively sealing blood flow around the device.

The first and only LAA Occluder for AF patients and cases like these

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

  • Comorbidities and concerns about 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.

  • Adherence or compliance issues

    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.
     

  • Daily activities that increase bleeding risk

    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 history of falls and a high risk of bleeding

    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.
     

  • A contraindication 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.

For educational purposes only; not real patient cases.

The first and only LAA occluder that ensures the best fit across the most diverse range of LAA anatomies1

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

The Amplatzer™ line pioneered the technology of structural heart occlusion devices and remains the leading choice for implanters worldwide. Amplatzer devices, and other life-changing innovations from Abbott, continue to transform futures.

130+

130+

DISCOVERING NEW WAYS TO MAKE LIFE BETTER FOR MORE THAN 130 YEARS2

160+

160+

MAKING A DIFFERENCE
IN OVER 160 COUNTRIES2

109K

109K

EMPLOYEES WORKING AROUND THE WORLD TO MAKE A LASTING IMPACT ON HEALTH2

Get the study results: Amulet™ vs Watchman‡


‡Indicates a third-party trademark, which is property of its respective owner.

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
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GET THE STUDY RESULTS: AMULET™ VS WATCHMAN‡

MAT-2111179 v2.0 | Item approved for U.S. use only.

References
  1. Amplatzer Amulet LAA Occluder Instructions for Use.
  2. 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.
  3. 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.
  4. 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.
  5. 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

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.

WARNINGS

  •  If the device is retracted while it is in the sheath, the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
  • If the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
  • Physicians must be prepared to deal with urgent situations, such as pericardial effusion or device embolization, which can require removal of the device.
  • This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device.
  • Late pericardial effusion events were observed in the clinical study. The use of post-procedure anticoagulation therapy may be associated with an increased potential for a late pericardial effusion. Physicians should monitor for signs and symptoms of pericardial effusion and obtain appropriate imaging when indicated. Physicians should also consider routine echocardiography to screen for pericardial effusion.
  • Remove embolized devices. Do not remove an embolized device unless the device is fully captured inside a sheath.
  • The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.
  • Do not use this device if the sterile package is open or damaged.
  • The device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use on or before the expiration date that is printed on the product packaging label.

PRECAUTIONS

  • The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of this device.
  • The physician should exercise caution if implanting a device in a patient who has an implantable cardioverter defibrillator (ICD) or pacemaker leads.
  • The physician should have the guidewire in the left upper pulmonary vein when making exchanges in the left atrium.
  • Ensure that the vasculature is adequate for the sheath size being selected.
  • The physician should exercise caution if performing ablation at or near the implant site after the device is implanted.
  • Use standard interventional cardiovascular catheterization techniques when using Amplatzer™ products.
  • Use in specific populations
    • Pregnancy – Minimize the radiation exposure to the fetus and the mother.
    • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

MRI SAFETY INFORMATION 

Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:

  • Static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)
  • Maximum spatial gradient field of 19 T/m (1900 G/cm)
  • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.

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
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