CorMatrix Cardiovascular, Inc., a medical device company dedicated to developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that a retrospective study demonstrated that reconstructing the pericardium using ECM™ Technology in patients undergoing primary isolated coronary artery bypass grafting (CABG) contributed to a statistically significant and clinically meaningful reduction in the rate of new onset postoperative atrial fibrillation. This research was published today in the online peer-reviewed journal The Heart Surgery Forum (www.hsforum.com/).
“These results were compelling enough that we sought FDA approval to see whether these important findings may be replicated in a prospective, randomized trial.”
Physicians from Mobile Infirmary Medical Center (Mobile, AL) and Trinity Medical Center (Birmingham, AL) performed a retrospective comparison of the incidence of new onset postoperative atrial fibrillation in 111 patients who had undergone pericardial reconstruction using CorMatrix ECM after primary isolated CABG, versus a control group of 111 patients who did not receive the treatment. Analysis of the study, which looked at all incidence of atrial fibrillation regardless of duration, showed that new onset postoperative atrial fibrillation occurred in 43 of 111 control patients but in only 20 of 111 treated patients, representing a 54% reduction in relative risk in the treatment group (P < 0.001).
New onset postoperative atrial fibrillation is the most common arrhythmic complication following cardiac surgery. In patients undergoing various cardiac procedures, the reported incidence is between 32% and 64% [Creswell 1993; Auer 2005; Echahidi 2008]. Furthermore, a recent retrospective analysis of over 16,000 consecutive patients undergoing CABG found an association between new onset postoperative atrial fibrillation and a 21% relative increase in mortality. The greatest negative impact on long-term survival was seen in women. [El-Chami 2010]
"We've heard anecdotally that the use of CorMatrix ECM to reconstruct the pericardium seemed to reduce the risk of postoperative atrial fibrillation, but this is the first time it has been studied in a retrospective analysis," said Robert G. Matheny, M.D., Chief Scientific Officer, CorMatrix Cardiovascular. "These results were compelling enough that we sought FDA approval to see whether these important findings may be replicated in a prospective, randomized trial."
CorMatrix has received conditional approval by the FDA and anticipates beginning the multi-center clinical trial of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation by November, 2010. Patients enrolled in the trial will undergo circumferential reconstruction of the normal pericardial anatomy following isolated, first-time CABG procedures and will be compared to subjects who do not undergo pericardial closure. The clinical trial is anticipated to enroll more than 400 patients at up to 15 cardiac surgery sites in the United States.
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