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August 17, 2021

Abbott’s Amulet approved by FDA for atrial fibrillation treatment

The FDA approval is based on data from Amulet IDE, a randomised, head-to-head trial of the device.

The US Food and Drug Administration (FDA) has approved Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder to treat individuals with atrial fibrillation (AFib) who are at risk of ischaemic stroke.

Using dual-seal technology, the less-invasive device provides quick closure of the left atrial appendage (LAA), a small pocket joined to the left atrium of the heart.

This lowers the risk of stroke and removes the need to take blood-thinning medication.

In AFib patients, the heart’s ability to pump blood efficiently can be impacted. This causes blood to accumulate in the LAA, increasing the risk of clotting.

Clots that enter the bloodstream can travel to the brain and cause a stroke.

For AFib patients who cannot take blood-thinning treatments in the long term, doctors can perform LAA occlusion or closure procedures using devices such as Amulet to seal off the LAA completely and reduce the risk of stroke.

The latest approval is based on findings from the large-scale randomised head-to-head Amulet IDE trial, which analysed Amulet against another less-invasive LAA occlusion device.

Abbott structural heart business senior vice-president Michael Dale said: “Amulet’s unique dual-seal approach has made it the number one LAA closure product in Europe, so today’s device approval by the FDA is an important milestone in allowing us to bring this treatment option to American physicians and patients.

“Consistent with our mission purpose, our minimally invasive Amulet procedure for reducing stroke risk in patients with atrial fibrillation will help people live better lives through better health.”

The company said that Amulet users do not require blood-thinning medication after the procedure.

The device can also be recaptured and repositioned to ensure the best placement. It is available in a wide range of occluder sizes for different anatomies.

In June, Abbott obtained CE mark approval for its Amplatzer Steerable Delivery Sheath for LAA occlusion procedures to treat AFib patients who are at increased risk of ischaemic stroke.

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