CorMatrix Cardiovascular: First Patient Enrolled in Multi-Center Clinical Trial of the CorMatrix(R) ECM(R) for Pericardial Closure to Reduce the Incidence of New Onset Postoperative Atrial Fibrillation
12/13/2010 6:22:25 AM
ATLANTA, Dec. 13, 2010 /PRNewswire/ -- CorMatrix Cardiovascular, Inc., an Atlanta-based 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 Franciscan Alliance/St. Francis Heart Center in Indianapolis, Indiana is the first site to enroll a patient in the multi-center clinical trial of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.
This prospective randomized controlled trial will enroll more than 400 patients in up to 15 trial sites across the U.S. The trial will assess the incidence of new onset postoperative atrial fibrillation in patients who undergo primary isolated coronary artery bypass grafting (CABG) and pericardial reconstruction using CorMatrix ECM, versus a control group of CABG patients for whom the pericardium will not be closed.
"CorMatrix is excited to initiate this study of pericardial reconstruction and looks forward to future studies that will explore the many potential uses of the CorMatrix ECM Technology," said Robert Matheny, MD, Chief Scientific Officer at CorMatrix. "We hope this clinical trial will stimulate interest within the healthcare community on the unique advantages of ECM technology and the future of remodeling cardiac tissue."
In October, results were published on a retrospective study of 222 patients comparing the incidence of new onset postoperative atrial fibrillation in primary isolated CABG patients who did and did not receive pericardial closure using CorMatrix ECM. Clinical outcomes of the 111 patients implanted with the CorMatrix ECM showed that new onset postoperative atrial fibrillation occurred in only 20 of 111 treated patients compared to 43 of 111 control patients, representing a 54% reduction in relative risk in the treatment group (P < 0.001).
"We've seen the significant results of the retrospective study published in Heart Surgery Forum and are encouraged by CorMatrix's commitment to pursue a prospective trial. We are excited to participate in this study because we believe reconstructing the pericardium with CorMatrix ECM will provide tremendous benefit to our patients," said Manesh Parikshak, MD, Cardiothoracic Surgeon at the Franciscan Alliance/St. Francis Heart Center, Indianapolis, and co-investigator for the trial. "This is a particularly important trial given the clinical and economic implications of new onset postoperative AF, and we are pleased to have enrolled the first patient."
CorMatrix ECM, a naturally occurring bioscaffold, has been successfully implanted in more than 25,000 patients in the U.S. It helps stimulate tissue growth by providing a location where the patient's cells can migrate and integrate with the ECM, eventually creating new tissue in place of the CorMatrix ECM.
"The unique properties of the CorMatrix ECM provide an excellent opportunity to repair the pericardium and reduce postoperative atrial fibrillation," said Marc Gerdisch, MD, Director of Cardiothoracic Surgery at the Franciscan Alliance/St. Francis Heart Center, Indianapolis, and overall Principal Investigator of the trial. "This trial has the potential to revolutionize treatment options for postoperative AF patients."
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, Inc.