CorMatrix(R) Announces FDA 510(k) for Novel Biomaterial Implant for Intracard... ( Company Also Announces CE Mark Appr...)

CorMatrix(R) Announces FDA 510(k) for Novel Biomaterial Implant for Intracardiac Repair

Date:5/8/2008

Company Also Announces CE Mark Approval for First Product, the CorMatrix

ECM(TM) for Pericardial Closure

ATLANTA, May 8 /PRNewswire/ -- CorMatrix Cardiovascular, Inc., an Atlanta- based company dedicated to developing and delivering unique extracellular matrix (ECM(TM)) biomaterial technologies that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CorMatrix ECM(TM) for Cardiac Tissue Repair, which utilizes the company's proprietary ECM Technology(TM).

The company's platform ECM Technology, an extracellular matrix biomaterial, provides 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.

"We have used the CorMatrix ECM to close the pericardium for the past two years. An intact pericardium plays an important role short and long term for the patient, both anatomically and functionally. Surgeons typically prefer to restore structures to their normal anatomy whenever possible, which we have been able to do in a safe and effective manner using the CorMatrix ECM. Post- operative CT scans on patients in which we have closed the pericardium have demonstrated the re-established pericardial anatomy complete with normal pericardial space," said Douglas Boyd, M.D., Chief of Cardiothoracic Surgery at the Cleveland Clinic in Weston, Florida.

"The ease of use and post-operative results make it an excellent option for pericardial closure and now for othe
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CorMatrix(R) Announces FDA 510(k) for Novel Biomaterial Implant for Intracard...( Company Also Announces CE Mark Appr...)