It was reported on Tuesday, that the US Food and Drug Administration (USFDA) has approved US-based Abbott's (NYSE:ABT) new trial designed to assess its Amplatzer Amulet Left Atrial Appendage Occluder for people with atrial fibrillation.
The Catalyst trial is reportedly the first-ever clinical trial comparing the effectiveness of a left atrial appendage closure device to a newer class of blood thinners, called non-vitamin K antagonist oral anticoagulant drugs, currently the standard treatment for atrial fibrillation. It will measure the effectiveness of the Abbott Amplatzer Amulet as an alternative treatment option.
Vivek Reddy, MD, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital, and the principal investigator, said, 'A device that can address a significant structural issue of the heart via a minimally invasive procedure would be a significant step forward for patients with atrial fibrillation eligible for long-term NOAC therapy. This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AF who are at an increased risk for ischemic stroke.'
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