The US Food and Drug Administration (FDA) has granted investigational device exemption approval to CorMatrix Cardiovascular for an ongoing, multicentre, prospective and randomised clinical trial of the CorMatrix ECM.
The trial will evaluate the safety and efficacy of the extracellular matrix for pericardial closure to minimise the incidence of occurrence of postoperative atrial fibrillation following isolated primary coronary artery bypass graft surgery.
Earlier studies demonstrated a considerable reduction in the rate of new onset post-operative atrial fibrillation in coronary artery bypass graft patients following pericardial reconstruction with the CorMatrix ECM.
CorMatrix Cardiovascular chief scientific officer Robert Matheny said that the company was on track to complete enrolment in the study, analyse the results and submit them for publication by the end of 2012.
"This trial will be important to evaluate if our CorMatrix implant can foster better outcomes in this subset of at-risk patients," Matheny added.