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CorMatrix Cardiovascular gets FDA IDE approval for CorMatrix ECM study

CorMatrix Cardiovascular has received the US Food and Drug Administration (FDA) conditional investigational device exemption (IDE) approval to start a clinical trial to demonstrate the safety and efficacy of CorMatrix extracellular matrix (ECM) for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.

The clinical trial, anticipated to enroll more than 400 patients at up to 15 cardiac surgery sites in the US, is being initiated by CorMatrix following analysis of data from a retrospective study that demonstrated a reduction in the rate of new onset postoperative atrial fibrillation in coronary artery bypass grafting (CABG) patients following pericardial closure with the CorMatrix ECM.

FDA cleared CorMatrix ECM supports tissue remodeling by allowing native cells to migrate and attach within the ECM and the body’s natural healing processes result in the ECM material being gradually resorbed and replaced by native tissue.

CorMatrix Cardiovascular chief scientific officer Robert Matheny said that they have 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.

“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,” Matheny said.