The device reduces stroke risk by sealing off the LAA. Credit: sweet_tomato / Shutterstock.

Abbott has reported late-breaking five-year positive data from a trial of its Amplatzer Amulet left atrial appendage (LAA) occluder for reducing the long-term need for blood-thinning medication in individuals with atrial fibrillation (AFib) at increased stroke risk.

Involving more than 1,800 participants, the ‘Amulet IDE’ study is a randomised study comparing two LAA occlusion devices, the company’s Amplatzer Amulet and Boston Scientific‘s Watchman device.

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Findings from the trial show that 94% of subjects with the Amplatzer Amulet were not on blood-thinner medication compared to 90.9% of those with the Watchman device.

Moreover, the Amplatzer Amulet was associated with a lower incidence of fatal or disabling strokes.

Further statistical evidence points to the device achieving superior LAA closure rates of 89.2% compared to 83.3% with the Watchman device.

Amulet IDE trial principal investigator Dhanunjaya Lakkireddy said: “With the five-year findings from Abbott’s Amulet IDE study, doctors can even more confidently offer AFib patients the minimally invasive Amulet device that not only closes the LAA and reduces their risk of stroke, but can also keep them off blood-thinning medication long-term.”

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The Amulet’s dual-seal design can treat a wide range of LAA anatomies, offering a durable solution for permanent closure, especially for patients who cannot tolerate long-term blood-thinning medication due to adverse effects such as bleeding.

The LAA Occluder has gained approval in more than 80 countries, including Australia, the US, Europe, and Canada, since its initial CE Mark in 2013 and the Food and Drug Administration (FDA) approval in 2021.

AFib interrupts the heart’s blood-pumping efficiency, potentially causing clots in the LAA that can lead to strokes. The Amplatzer Amulet addresses this problem by providing a minimally invasive alternative for patients by reducing stroke risk by sealing off the LAA.

Abbott Structural Heart Solutions’s senior vice-president Sandra Lesenfants said: “For years, doctors and their patients only had one minimally invasive option to close the LAA.

“The Amplatzer Amulet redefined LAA closure by offering dual-seal technology that completely and immediately seals the LAA without requiring blood-thinning medication following the procedure.

“These data reinforce that the Amulet device is safe and effective, and also, importantly, that it’s helping people enjoy their lives and worry less about the risk of having a stroke.”