CorMatrix Cardiovascular has completed a trial of its CorMatrix ECM technology and confirmed safety of its usage to close the pericardium of patients undergoing postoperative coronary artery bypass grafting (CABG).
Preliminary results show that the study’s safety endpoints concerning the use of the device close to the pericardium were met.
However, the primary endpoint of new onset postoperative atrial fibrillation was not met, with no statistically significant difference between treatment and control groups.
As part of the New Onset Post-Operative Atrial Fibrillation Clinical Trial, the new technology was trialled on patients undergoing first-time CABG at 15 US clinical sites.
CorMatrix chairman and CEO David Camp said; “We will continue to evaluate the clinical trial data to better understand the factors that may affect postoperative atrial fibrillation.”
The trial also eliminated concerns that closing the pericardium may cause coronary bypass grafts to ‘kink’ and close postoperatively, and also showed no drastic change in the incidence of graft occlusion when using CorMatrix ECM technology.
CorMatrix ECM, which is a naturally-occurring extracellular matrix biomaterial, supports native tissue repair by allowing a patient’s own cells to repopulate and fix damaged tissues.
Deployed at over 720 hospitals across the US, the CorMatrix ECM has been implanted in patients during 70,000 cardiac processes.