Abbott has announced new late-breaking data that support the long-term benefits of its Amplatzer Amulet Left Atrial Appendage (LAA) Occluder for people with atrial fibrillation (AFib) at risk of stroke.
The Amplatzer Amulet is a heart closure device designed to prevent blood clots from forming in the LAA, thereby reducing the risk of stroke in patients with AFib.
The Amplatzer Amulet IDE trial included over 1,800 patients and compared Abbott’s Amplatzer Amulet LAA Occluder with Boston Scientific’s Watchman device.
The new five-year findings showed that the Amplatzer Amulet helps more patients avoid long-term blood thinner medication use than the Watchman device.
Key benefits include lasting outcomes, effective LAA closure, and a reduced need for blood-thinning medication. Abbott stated that these factors are crucial when selecting an LAA closure option for patients.
The five-year findings from this global clinical trial showed that a statistically higher percentage of Amplatzer Amulet patients were not using blood-thinning medication compared with Watchman patients.
Additionally, the trial found a significantly lower number of fatal or disabling strokes in the Amplatzer Amulet group compared to the Watchman group.
The data also demonstrated superior LAA closure with Amplatzer, achieving a closure rate of 89.2%, compared to 83.3% with Watchman.
These results highlight the Amplatzer Amulet’s effectiveness in reducing stroke risk and the need for long-term blood thinners.
Abbott structural heart business senior vice president Sandra Lesenfants said: “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.”
In a separate development, Abbott opened its manufacturing facility in Kilkenny, Ireland.
The new site will serve as a global manufacturing centre of excellence for Abbott’s diabetes care business and is expected to employ more than 800 people.
The Kilkenny facility is part of a €440m investment in Ireland, which also includes a major expansion of Abbott’s Donegal site, creating an additional 200 jobs.
The new 30,000m2 Kilkenny facility will produce the FreeStyle Libre 3 sensors for continuous glucose monitoring.
Additionally, the healthcare technology firm is expanding its manufacturing capacity across Europe with an £85m investment in its Witney facility in Oxfordshire, UK.
