FDA grants IDE approval to CorMatrix for extracellular matrix study for pericardial closure


The US Food and Drug Administration (FDA) has granted full investigational device exemption (IDE) to CorMatrix for its ongoing multicentre, prospective, randomised clinical trial aiming to demonstrate the safety and efficacy of the CorMatrix extracellular matrix (ECM) for pericadial closure to reduce the incidence of new onset postoperative atrial fibrillation following isolated primary coronary artery bypass graft (CABG) surgery.

Up to now, the clinical trial has enrolled more than 80% of the planned 440 total subjects. This prospective trial was initiated based on a previous retrospective study that demonstrated a statistically significant reduction in the rate of new onset postoperative atrial fibrillation in CABG patients following pericardial reconstruction with the CorMatrix ECM. As the current CorMatrix trial moves towards completion, positive results would be yet another milestone determining the role of pericardial reconstruction using the CorMatrix material in cardiovascular surgery.

“We are pleased with the FDA’s decision to provide us with full approval for this significant trial, and we are on track to complete enrolment in the study, analyse the results and submit them for publication by the end of next year,” said Robert G Matheny, chief scientific officer, CorMatrix Cardiovascular. “We continue to encounter data from the clinical community suggesting an increase in observed postoperative atrial fibrillation and the significant impact both clinically and economically to the healthcare system. This trial will be important to evaluate if our CorMatrix implant can foster better outcomes in this subset of at-risk patients.”

Following cardiac surgery, new onset postoperative atrial fibrillation is the most common arrhythmic complication, with reported incidence between 32% and 64%, posing a serious concern for patients undergoing cardiac surgery procedures [Creswell 1993; Auer 2005; Echahidi 2008]. A recent retrospective analysis of more than 16,000 patients with no history of atrial fibrillation who underwent CABG surgery found an association between new onset postoperative atrial fibrillation and a 21% relative increase in mortality, with the greatest negative impact seen in the long-term survival of women [El-Chami 2010].

“Trials designed to test preventative measures for postoperative atrial fibrillation are not only interesting, but they are necessary given the need to improve outcomes and create more effective and cost-efficient models of healthcare,” commented James L Cox, Emeritus Evarts A. Graham professor of Surgery, Washington University School of Medicine, Barnes-Jewish Hospital, St Louis, president and CEO, World Heart Foundation, and CorMatrix Scientific Advisory Board member. “Medical advancements to reduce postoperative arrhythmias have not materialised, and we continue to see an increase in the number of patients encountering these symptoms. With bypass surgery continuing to be an unfortunately common procedure, it is imperative that surgeons are given options to help improve patient care and reduce unwanted outcomes, while reducing the overall cost-burden to the healthcare system.”

About extracellular matrix biomaterial

The unique properties of extracellular matrix biomaterials were discovered at Purdue University. The decellularised matrix material serves as a scaffold to allow adjacent tissues to deliver cells and nutrients to the matrix, which then differentiate into tissue-specific cells. The ECM material is gradually replaced as the patient’s own body reinforces and rebuilds the weakened site. During the repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where scar tissue or injured tissue would normally be expected.