US-based CorMatrix Cardiovascular has completed trial on its ECM technology that helps in closing the pericardium of patients undergoing postoperative coronary artery bypass grafting (CABG) and said the trial results confirm its safe use.
The medical device firm conducted its New Onset Post-Operative Atrial Fibrillation Clinical Trial on patients undergoing first-time CABG at 15 US clinical centers.
After observing the outcomes of post-operative clinical and the incidence of selected complications, the study captured its primary and secondary safety endpoints when CorMatrix ECM was deployed to close the pericardium.
CorMatrix chairman and CEO David Camp said the company will continue to evaluate the clinical trial data to improve its understanding over the factors likely to affect postoperative atrial fibrillation.
"We are highly encouraged by the study's excellent safety results and by the growing acceptance of this regenerative technology in the marketplace," said Camp.
The safety trial had shown no drastic variation in the incidence of cardiac tamponade while using CorMatrix ECM to develop a water-tight seal of the pericardium upon cardiac surgery.
Besides, the trial also confirmed no major deviation in the incidence of graft occlusion during the usage of ECM technology, thereby clearing the concerns that closure of pericardium would lead to coronary bypass grafts.