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news.CorMatrix Cardiovascular has received 510(k) clearance from the FDA for its CorMatrix ECM for Cardiac Tissue Repair, which utilizes the company's proprietary ECM Technology.
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The company’s platform ECM Technology, an extracellular matrix biomaterial, is said to provide a natural bioscaffold that enables a patient’s own host cells to repopulate and repair damaged tissues. The CorMatrix ECM is currently FDA cleared for the reconstruction and repair of the pericardium.
The additional indication expands the use of the implant to include suture-line reinforcing, buttressing for soft tissue reaproximation, repair of cannulation sites and bleeding sites, and as an intracardiac patch or pledget for tissue repair of structural problems such as septal defects.
The company also received CE Mark approval in the first quarter of 2008 for the CorMatrix ECM for pericardial closure and anticipates launching this product in Europe and other international markets later this year.
Douglas Boyd, chief of cardiothoracic surgery at the Cleveland Clinic in Weston, Florida, said: “We have used the CorMatrix ECM to close the pericardium for the past two years. As with pericardial closure, intracardiac repair using the CorMatrix ECM restores the natural anatomy of the heart. We are pleased that this additional approval will allow us to use the material beyond the pericardium.”