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 WATCHMAN‡2.5
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 WATCHMAN‡AT 12 MONTHS3
‡Indicates a third-party trademark, which is property of its respective owner.
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
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
DURING FOLLOW UP
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.
SAMPLE SIZE LOCATION Amulet Investigational Device Exemption (IDE) 1,878 US, Canada, Europe, Australia Amulet Observational Study 1,088 Europe, Asia, Australia LAAO Post Approval Study >1,000 Canada, Latin America, Europe
MAT-2201604 v1.0 | Item approved for Global OUS use only.