After being approved by the Food and Drug Administration, Abbott Laboratories will compete fiercely with rival Boston Scientific, and the device is designed to prevent strokes in patients with atrial fibrillation.
Because patients with atrial fibrillation face an increased risk of stroke, they are often prescribed blood thinners as a preventive measure. Although this is still the standard of care, some patients may not be able to take blood thinners for long periods of time. In 2015, Boston Scientific’s Watchman Device was approved, which is an implantable device designed to replace anticoagulants.
Abbott’s newly approved Amulet device will act as a direct competitor. It is approved for patients with atrial fibrillation who are at risk of ischemic stroke and who have reason to look for alternatives to blood thinners.
It closes the left atrial appendage, which is an area where blood can collect and can form clots in people with atrial fibrillation. However, unlike Boston Scientific’s equipment, Abbott claims that patients do not need to take anticoagulants for a period of time after surgery.
Michael Dell, senior vice president of Abbott’s structural heart business, stated in a press release that this approach helped Abbott gain market share in Europe and received CE mark approval in 2013.
Abbott submitted a result 150 site clinical trials As part of the FDA approval process, compare these two devices. More than 1,800 patients were randomly allocated between their Amulet device or Boston Scientific’s Watchman device.
Abbott spokesperson Cynthia Kong said on the phone that it has not announced the results of the study, but plans to share it with the European Society of Cardiology later this month.
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