St. Jude Medical, a healthcare products company based in Little Canada, Minnesota, announced that its Amplatzer Amulet left atrial appendage closure device received CE Mark approval from the European Union. According to a press release, the Amplatzer Amulet device is designed to close the left atrial appendage of the heart in patients with an increased risk of stroke from non-valve atrial fibrillation.
The device is designed for physician-assisted insertion through a specialized catheter. Once inserted, the device attaches to a patient’s left atrial appendage. The left atrial appendage, a hollow structure, is one of the main sites of blood clots in patients diagnosed with atrial fibrillation. The Amplatzer Amulet includes many of the same features found in the Cardiac Plug, an earlier version of the device. However, the Amplatzer Amulet is indicated for a wider range of patient anatomies.
Frank Callaghan is the president of St. Jude’s cardiovascular division. In prepared remarks, he said, "Feedback from implanting physicians who have used our 1st-generation product has been instrumental to improving an already successful device." He continued, "We are pleased to offer a next-generation LAA occluder that addresses a wider range of patient anatomies, is easier to implant, and has the potential to further reduce the incidence of stroke in AF patients."
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