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News Release - October 25, 2010
Study Finds Correlation Between Pericardial Reconstruction with CorMatrix ECM(TM) Technology and Reduced Risk of Postoperative Atrial Fibrillation in CABG PatientsPositive Preliminary Findings Provide Impetus for Prospective Study of CorMatrix ECM Technology for Pericardial Reconstruction
ATLANTA--(Healthcare Sales & Marketing Network)-- 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/).
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.
Auer J, Weber T, Berent R, Ng CK, Lamm G, Eber B. 2005. Risk factors of postoperative atrial fibrillation after cardiac surgery. J Card Surg 20:425-31.
Creswell LL, Schuessler RB, Rosenbloom M, Cox JL. 1993. Hazards of postoperative atrial arrhythmias. Ann Thorac Surg 56:539-49.
Echahidi N, Pibarot P, O’Hara G, Mathieu P. 2008. Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery. J Am Coll Cardiol 51:793-801.
El-Chami MF, Kilgo P, Thourani V, et al. 2010. New-Onset Atrial Fibrillation Predicts Long-Term Mortality After Coronary Artery Bypass Graft. J Am Coll Cardiol 55: 1370–6.
About Extracellular Matrix Biomaterial
The unique properties of extracellular matrix biomaterials were discovered at Purdue University. The decellularized 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.
The use of extracellular matrix materials in non-cardiovascular applications has established a significant foothold in soft tissue repair, wound management and orthopedic applications. The safety of extracellular matrices has been well established in a number of different clinical applications. The extracellular matrix has been studied extensively, with more than 500 published papers. Since 1999, an estimated 500,000 patients worldwide have received an extracellular matrix implant.
About CorMatrix ECM Technology
CorMatrix Cardiovascular holds an exclusive license from Purdue University to research, develop, manufacture and market naturally occurring ECM products for cardiovascular applications. The company currently has U.S. clearance and European approval with a CE Mark for its ECM Technology as an implant for pericardial closure and for use in cardiac tissue repair.
About CorMatrix Cardiovascular, Inc.
CorMatrix Cardiovascular, a privately held company based in Atlanta, Georgia, is dedicated to developing and delivering innovative cardiovascular devices that harness the body’s innate ability to remodel damaged tissue. For more information, visit www.cormatrix.com.
Source: CorMatrix Cardiovascular
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