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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 CorMatrix Cardiovascular Inc. has received 510(k) clearance from the FDA for its CorMatrix ECM(TM) for Cardiac Tissue Repair, which utilizes the company’s proprietary ECM Technology(TM). The company’s platform ECM Technology provides a natural bioscaffold that enables a patient’s own host cells to repopulate and repair damaged tissues. The CorMatrix ECM, which is currently cleared for the reconstruction and repair of the pericardium, can now be used for suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects.