AMPLATZER™ AMULET™ LAA OCCLUDER
The #1 Company in Structural Interventions1 | Thousands of Patients Treated Worldwide1
Atrial Fibrillation (AF) and Stroke in Australia2-5
It is estimated that 55K Australians have a stroke every year
The majority of strokes (~87%) are ischaemic
The majority of blood clots are located in the left atrial appendage (LAA) in patients with non-valvular AF
An older population is approximately 5 times more likely to have a stroke
Are there any treatment options to reduce the risk of stroke in AF patients?6-8
There are a number of treatment options to reduce the risk of stroke, such as:
Blood thinners or anticoagulation therapies, though these may cause side effects and an increase in the risk of bleeding complications.
Surgery, depending on the severity and symptoms.
LAA occlusion with a device using a catheter-based procedure.
Current evidence suggests that LAA occlusion can be effective in reducing the risk of blood-clot related complications in those with non-valvular AF and is an option for people who have bleeding problems while taking anticoagulants.
*The testimonials does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual's experience and might not be representative of others.
References
1. Data on file at Abbott.
2. Fuster V, et al. ACC/AHA/ESC Practice Guidelines. Circulation. 2006;114:700-752.
3. Chanda A, et al. Left atrial appendage occlusion for stroke prevention. Prog Cardiovasc Dis. 2017;59(6):626-635.
4. Al-Saady NM, et al. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999;82:547–555.
5. Bajwa RJ, et al. Left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation. Clin Cardiol. 2017;40:825-831.
6. Suradi HS, et al. Left atrial appendage closure: outcomes and challenges. Neth Heart J. 2017;25:143-151.
7. Kirchhof P, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016;18:1609–1678.
8. Meier B, et al. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. EP Europace. 2014;16(10):1397–1416.
Discover the Amplatzer™ Amulet™ Left Atrial Appendage (LAA)
Occluder2-6
The Amplatzer™ Amulet™ LAA Occluder is a percutaneous transcatheter device intended to prevent thrombus embolisation from the LAA in patients who have non-valvular atrial fibrillation (AF).
Finally closure is an option for patients who:
Have had a bleeding event
Are at high risk for falls
Are at risk for drug interactions
Are unwell or unwilling to adhere to routine monitoring
The Amplatzer™ Amulet™ LAA Occluder Features
Dual Seal Technology to Completely Seal the Orifice7,8
Innovative dual seal design, provides an immediate and complete ostial seal, leveraging of a proven AmplatzerTM design that has been trusted for over 20 years.
Innovative, Trusted Design Makes the Difference
Watch the Amplatzer™ Amulet™ LAA Occluder in Action
References
1. Data on file at Abbott.
2. 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.
3. Amplatzer Amulet LAA Occluder Instructions for Use.
4. Lakkireddy D, et al. Amplatzer™ Amulet™ Left Atrial Appendage Occluder versus Watchman™ device for stroke prophylaxis (Amulet IDE): A randomized controlled trial. Circulation. 2021;144:1543–1552.
5. Suradi HS, et al. Left atrial appendage closure: outcomes and challenges. Neth Heart J. 2017;25:143-151.
6. 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.
Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder Clinical Evidence
The AmplatzerTM AmuletTM LAA Occluder's safety and performance have been well documented and trials continue to demonstrate its efficacy.
In a study of 302 patients, 151 were treated with left atrial appendage (LAA) occlusion and 151 were treated with medical management.2
Risk Reduction vs Predicted Stroke Risk3
Patients in the Amulet Observational Study experienced:
References
Referral
In Australia, this procedure is indicated in a patient who has non-valvular atrial fibrillation and a contraindication to life-long oral anticoagulation therapy, and is at increased risk of thromboembolism demonstrated by:
(a) a prior stroke (whether of an ischaemic or unknown type), transient ischaemic attack or non-central nervous system systemic embolism; or
(b) at least 2 of the following risk factors:
(i) an age of 65 years or more;
(ii) hypertension;
(iii) diabetes mellitus;
(iv) heart failure or left ventricular ejection fraction of 35% or less (or both);
(v) vascular disease (prior myocardial infarction, peripheral artery disease or aortic plaque)
When considering treatment options, the safety and effectiveness of device closure compared to oral anticoagulation therapy and the above indications should be taken into account. A shared decision-making process between the patient and the medical team is recommended.
For more on referral, click below to access our brochures
Procedure
Insertion of the Amplatzer™ Amulet™ left atrial appendage (LAA) Occluder device involves:
1. Measure the LAA orifice landing zone and depth.
2. Deploy the lobe of the AmplatzerTM AmuletTM occluder in the landing zone of the LAA.
3. Deploy the disc of the AmplatzerTM AmuletTM device to fully cover the LAA ostium.
4. Release the AmplatzerTM AmuletTM device from the delivery cable.
References
1. Data on file at Abbott.
2. Stroke Foundation. Clinical Guidelines for Stroke Management. Available at https://informme.org.au/en/Guidelines/Clinical-Guidelines-for-StrokeManagement. Accessed April 2022.
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