ATLANTA, Sept. 10 /PRNewswire/ -- CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy 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.
The clinical trial, anticipated to enroll more than 400 patients at up to 15 cardiac surgery sites in the United States, is being initiated by CorMatrix following analysis of data from a retrospective study that demonstrated a statistically significant reduction in the rate of new onset postoperative atrial fibrillation in CABG patients following pericardial closure with the CorMatrix ECM. Data from this retrospective study have been accepted and will soon be published in a peer-reviewed journal.
"We've heard anecdotally for some time that the use of CorMatrix ECM technology to reconstruct the native pericardial anatomy seems to reduce the risk for new onset postoperative atrial fibrillation," said Robert G. Matheny, M.D., Chief Scientific Officer, CorMatrix Cardiovascular. "Following a review of the retrospective data and the growing data on the incidence and significance of postoperative atrial fibrillation, we believe this is an important study to undertake."
Following cardiac surgery, new onset postoperative atrial fibrillation is the most common arrhythmic complication, with reported incidence between 32% and 64%, and poses 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].
"Postoperative atrial fibrillation is a significant concern for patient outcomes," added James L. Cox, MD, Emeritus Evarts A. Graham Professor of Surgery, Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, MO, President and CEO, World Heart Foundation, and CorMatrix Scientific Advisory Board member. "Despite efforts over the last 30 years to reduce postoperative arrhythmias, we continue to see a high incidence level and increased risk of death for patients. Ongoing study of new approaches is both warranted and encouraging as surgeons strive to further advance our care of patients undergoing bypass surgery."
CorMatrix ECM for Pericardial Closure received 510(k) clearance from the FDA in 2006 for the reconstruction and repair of the pericardium. CorMatrix ECM supports tissue remodeling by allowing native cells to migrate and attach within the ECM. The body's natural healing processes result in the ECM material being gradually resorbed and replaced by native tissue. Preclinical data suggests that reformation of the pericardial space provides a solution for surgeons to reconstruct the pericardium and restore the normal anatomic structure. The prospective clinical trial is being initiated under an IDE to investigate the safety and effectiveness of implanting CorMatrix ECM for Pericardial Closure for a new clinical indication to reduce the incidence of new onset postoperative atrial fibrillation.
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. 510(k) clearance and European CE Mark approval for its ECM Technology as an implant for pericardial closure and for use in cardiac tissue repair. Since commercial launch, more than 25,000 CorMatrix ECM devices have been implanted at more than 400 hospitals in the United States and Europe.
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.
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.
|SOURCE CorMatrix Cardiovascular, Inc.|
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