Atrial Fibrillation (AFib) and Stroke

Stopping blood thinners is a real possibility for people with non-valvular atrial fibrillation. A doctor likely prescribed a blood thinner to reduce the risk of stroke at the time of diagnosis. Blood thinners, also called oral anticoagulants, are pills or tablets that thin the blood to help prevent clots.²

Blood thinners cause side effects that many people find troubling and lead them to stop or seek alternatives.^3-5 Unsightly bruises or fear of falls and cuts can interfere with people’s ability to do activities they enjoy like cooking, sewing, traveling, cycling, playing with grandchildren.

Yes, the Amplatzer Amulet occluder reduces stroke risk without the need for blood thinners immediately after the procedure in most cases.⁶

Blood thinners are most common way to reduce stroke risk for people with AFib. But many people are not able to take blood thinners long term. In fact, 1 in 4 people stop taking blood thinners.

• Increased risk of bleeding
• Unpleasant side effects
• Costs
• The need for constant blood testing
• Other medical conditions

No. The left atrial appendage is a normal part of the heart’s anatomy, but the heart works just as well when the LAA is closed.⁷

No. There will be a one-time procedure called Left Atrial Appendage Occlusion, or LAAO. The procedure typically takes 1-2 hours in a heart catheterization lab. Most people go home the next day.

The LAAO procedure only requires a small incision in the upper leg through which the doctor threads a catheter into the heart. Doctors use the same type of procedure when people need a stent or have a heart valve that needs to be repaired or replaced. Once the Amulet occluder is in place, it stays in the heart permanently to protect the patient.

Everyone is different. The goal is for the patient not to feel any pain or discomfort during the procedure. The doctor will make sure to use only as much anesthesia or sedation necessary to keep the patient pain free and relaxed.

Patients are typically discharged within 24 hours. The procedure typically takes 1-2 hours and is performed in a heart catheterization lab. This lab is a special area or location where minimally invasive procedures are performed.

No. Patients won’t be able to feel the device once it is inserted. The Amulet occluder stays in the heart permanently to protect the patient.

Reducing stroke risk and restoring the patient’s quality of life are of primary importance to the doctor. The Amulet occluder is highly effective in achieving both goals, right away.

The Amulet occluder has been the #1 device for LAAO occlusion in Europe since 2013. This device is available globally.

The Amulet occluder is a small device that seals off the area of the heart where 90% of stoke-producing blood clots form. This area is called the left atrial appendage, or LAA. The procedure to receive this device is called Left Atrial Appendage Occlusion, or LAAO. This minimally invasive procedure prevents clots that may have formed in the LAA from escaping into the body where they can pose a risk of stroke.¹

The device has a unique design that completely seals the left atrial appendage. Only the Amulet occluder has two connected parts that work together to close the LAA, like a lock and key. One part of the device seals off the appendage.

The other part secures the seal. And, because every patient’s LAA is unique, your doctor will choose the Amulet occluder shape and size that will work for you.

There are two ways the occluder helps someone with non-valvular AFib:

First, and most importantly, it reduces the risk of stroke. Closure of the left atrial appendage with the Amulet occluder is a one-time procedure.

Second, and important to a patient’s quality of life, the Amulet occluder makes it possible for the patient to stope taking blood thinners.

Success, considered effective closure, with the Amulet occluder was 98% in the clinical study on which the FDA based its approval.⁸

In the clinical trial on which the FDA based its approval of the Amulet occluder, less than 5% of patients experienced a procedure-related complication.⁸ Eighteen months after the procedure, rates of expected safety issues (thrombosis, embolism, and stroke) were all less than 5% and were even lower with the Amulet occluder than with the device to which it was compared.

The Amulet occluder does not require ongoing monitoring, unlike some blood thinners. Before the procedure, the doctor will use special imaging instruments to measure size of the left atrial appendage. These measurements guide the doctor to select the right size occluder for the appendage. Then, before the procedure is finished, the doctor will assess the placement of the device using special imaging instruments. Only when the doctor is confident that the Amulet occluder is exactly where it needs to be, will it be placed there permanently to protect the patient. There may be follow-up imaging to ensure complete closure and that the heart tissue has grown over the device.