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STRUCTURAL INTERVENTIONS

AMPLATZER™ AMULET™ LAA OCCLUDER CLINICAL DATA

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

STROKE RISK REDUCTION, AND FREEDOM FROM ANTICOAGULANTS

Clinical studies have shown that implanting AFib patients with the Amplatzer Amulet occluder is a safe and effective treatment option to reduce their risk of stroke and eliminate the need for oral anticoagulants.

99%3

SUCCESS
RATE

99%1

effective
closure

96%2

free from OAC use after 3 years

67%3

reduction in stroke risk

CLICK THE LINKS BELOW TO LEARN MORE
ABOUT AMULET OCCLUDER DATA

 

THE AMULET OCCLUDER DEMONSTRATES SUPERIOR CLOSURE, SIGNIFICANTLY HIGHER FREEDOM FROM OACS AND A TREND TOWARD GREATER SURVIVAL

Head-To-Head study demonstrates 63% lower risk of moderate or greater leaks with Amulet occluder4

Amulet occluder patients had significantly higher complete LAA closure rate by TEE compared to Watchman‡ device at both 45 days and 12 months.

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

  • Superior Closure

    The Amulet Occluder showed significantly better closure compared to Watchman‡ 2.5 and Watchman‡ flx5,6
     

    AMULET IDE CLOSURE AT 12 MONTHS

    SWISS-APERO COMPLETE CLOSURE AT 45 DAYS BY TEE


    SIGNIFICANTLY HIGHER COMPLETE CLOSURE
     

  • Better Outcomes

    The Amulet Occluder showed significantly higher freedom from OACS and a trend toward greater survival2
     

    AMULET IDE ORAL ANTICOAGULATION USAGE

    AMULET IDE ALL-CAUSE DEATH AT 3 YEARS

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

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MAT-2212398 v3.0 | Item approved for U.S. use only.

References
  1. Lakkireddy et al. Amplatzer Amulet Left Atrial Appendage Occluder versus Watchman Device for Stroke Prophylaxis (Amulet IDE). Circulation. 2021.
  2. Lakkireddy D, Thaler D, Ellis CR, et al. 3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE). JACC: Cardio Int. 2023. 16 (15):1902-1913
  3. Hildick-Smith D, Landmesser U, Camm AJ, et al. Left atrial appendage occlusion with the Amplatzer™ Amulet™ device: full results of the prospective global observational study. European Heart Journal. 2020.
  4. Ellis et al. HRS 2022.
  5. Ellis et al., Incidence and Clinical Outcomes of Peri-Device Leak After Transcatheter LAAO. HRS. 2022.
  6. Galea et al. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS- APERO Randomized Clinical Trial. Circulation 2022 145:724-738.
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.

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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