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

AMULET IDE STUDY VS WATCHMAN2.5

Superior, durable, complete closure
Proven in first large scale head-to-head trial2-3

Effective closure with ≤5 mm residual jet around the device at 45 days2

Complete closure with 0 mm residual jet around the device at 45 days2

MODERATE LEAKS (≥ 3 MM) MORE THAN 2X AS COMMON WITH WATCHMANAT 12 MONTHS3 


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GLOBAL STUDY REVEALS EXCELLENT PERFORMANCE IN HIGH-RISK PATIENTS

The safety and performance of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder has been well documented and published.1 Trials continue to demonstrate its efficacy. 
 

Global Amplatzer Amulet 
observational study4

This multicenter, prospective, real world registry included 1,088 patients:

  • Who were at high risk of stroke and bleeding
  • Who had paroxysmal, persistent, or longstanding nonvalvular atrial fibrillation

Because the vast majority of patients had a history of major bleeding, they were relatively or absolutely contraindicated for oral anticoagulation therapy. The observational study shows high implant success rates, as well as few periprocedural complications. Outcomes are as shown.5
 

High success rates

99%

IMPLANT
SUCCESS RATE

98.2%

CLOSURE RATES
DURING FOLLOW UP

Low periprocedural complication rates

0%

EMBOLIZM

0.2%

STROKE

0.9%

MAJOR VASCULAR COMPLICATION

These patients were followed for two years and patients experienced a reduction in ischemic events when compared to a predicted rate based on their stroke risk.4


Risk reduction vs predicted stroke risk based on CHA2DS2-VASc score

Patients in the Amulet Observational Study experienced: A 67% risk reduction in ischemic stroke events compared to predicted events.

  • Left Atrial Appendage Occlusion in patients with prior intracerebral hemorrhage

    Atrial fibrillation patients indicated for oral anticoagulation who had intracranial bleeding constitute a particularly difficult group with respect to their stroke risk management. In many cases these patients do not receive anticoagulation therapy due to concerns for recurrent intracranial bleeding or intracerebral hemorrhage (ICH).

    Nielsen-Kudsk conducted a propensity score matched trial that compared 147 patients with LAA occlusion (LAAO) and 147 standard care patients matched according to stroke and bleeding risks (CHA2DS2-VASc and HAS-BLED scores).6

    When comparing LAAO to standard care, LAAO showed a significant risk reduction of the following:

    • Combined endpoint of ischemic stroke, major bleeding, mortality: 81% relative risk reduction
    • Ischemic stroke: 65% relative risk reduction
    • Major bleeding: 61% relative risk reduction
    • Recurrent intracerebral hemorrhage: 71% relative risk reduction
    • All-cause mortality: 92% relative risk reduction
  • Investing in a growing body of evidence

    Though the Amplatzer Amulet LAA Occluder has been successfully used for a number of years, Abbott is committed to investing in research to validate and further quantify the therapy’s potential benefits. Ongoing studies include the following.

    STUDY

    SAMPLE SIZELOCATION
    Amulet Investigational Device Exemption (IDE)1,878US, Canada, Europe, Australia
    Amulet Observational Study1,088Europe, Asia, Australia
    LAAO Post Approval Study>1,000Canada, Latin America, Europe

MAT-2201604 v1.0 | Item approved for Global OUS use only.

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MAT-2000631 v10.0 | Item approved for OUS use only.

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