CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for P...
ATLANTA, Sept. 10 /PRNewswire/ -- CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy 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.
The clinical trial, anticipated to enroll more than 400 patients at up to 15 cardiac surgery sites in the United States, is being initiated by CorMatrix following analysis of data from a retrospective study that demonstrated a statistically significant reduction in the rate of new onset postoperative atrial fibrillation in CABG patients following pericardial closure with the CorMatrix ECM. Data from this retrospective study have been accepted and will soon be published in a peer-reviewed journal.
"We've heard anecdotally for some time that the use of CorMatrix ECM technology to reconstruct the native pericardial anatomy seems to reduce the risk for new onset postoperative atrial fibrillation," said Robert G. Matheny, M.D., Chief Scientific Officer, CorMatrix Cardiovascular. "Following a review of the retrospective data and the growing data on the incidence and significance of postoperative atrial fibrillation, we believe this is an important study to undertake."
Following cardiac surgery, new onset postoperative atrial fibrillation is the most common arrhythmic complication, with reported incidence between 32% and 64%, and poses a serious concern for patie