CorMatrix Receives FDA IDE Approval To Begin Prospective, Randomized Evaluation Of New Onset Postoperative Atrial Fibrillation
CorMatrix Cardiovascular, Inc. announced that FDA has granted conditional approval for the start of a multi-center, randomized clinical trial to demonstrate the safety of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation. Patients enrolled in the trial will undergo circumferential reconstruction of the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures and will be compared to subjects who do not undergo pericardial closure.
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A new algorithm can now detect atrial fibrillation with a 95 accuracy. This is a huge improvement over previous methods. Atrial fibrillation, which affects about three million Americans, is an independent risk factor for death and a major cause of ischemic stroke, in which blood flow is reduced to part of the brain. Atrial Fibrillation can be treated, but it is notoriously difficult to detect. The new algorithm was developed by Ki H. Chon, PhD, head of the Department of Biomedical Engineering at Worcester Polytechnic Institute (WPI), in partnership with Snehraj Merchant of The ScottCare Corporation.