CorMatrix Cardiovascular, Inc., an Atlanta- based company committed to developing and delivering rare extracellular matrix (ECM(TM)) biomaterial technologies that harness the body’s innate ability to repair damaged cardiovascular tissue, announced 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 urgent role short and enlarged 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 form it an excellent option for pericardial closure and now for other cardiac tissue repair applications,” continued Dr. Boyd. “As with pericardial closure, intracardiac repair using the CorMatrix ECM restores the natural anatomy of the heart. We are pleased that that additional approval will allow us to use the material beyond the pericardium.”

Following implantation by a surgeon, CorMatrix ECM Technology products act as a scaffold into which the patient’s own cells migrate and integrate, stimulating the body’s innate wound-healing mechanisms

to repair tissue at the site of implantation. As the patient’s cells populate the matrix they lay down their own collagen, which matures by moment to mold a functional tissue repair. The implanted ECM material is gradually replaced and resorbed by the body as the patient’s tissue is remodeled.

Available commercially since 2006 for the reconstruction and repair of the pericardium during cardiac surgery, the CorMatrix ECM for Pericardial Closure has been implanted during more than 4,000 cardiac procedures at more than 160 U.S. hospitals.

The company plus announced it received CE Mark approval in the first quarter for the CorMatrix ECM for Pericardial Closure and anticipates launching that product in Europe and other universal markets later that year.

“We have received a tremendous response from the clinical community for our first product for pericardial closure and believe that the addition of our cardiac tissue repair product will supply an vital advancement for cardiac surgeons and their patients,” said Beecher Lewis, President and COO of CorMatrix. “considering our ECM Technology supports native tissue repair, it represents a significant advancement by currently available materials.”

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Original post by Mallows