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).