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Repairing a Damaged Heart
If your physician has told you that you need heart surgery, you are not alone. According to the American Heart Association, one in three Americans have some form of heart disease. Advances in open heart surgery continue to improve outcomes for patients with weak or damaged hearts and more recently, new advances in cardiac tissue repair devices are helping physicians repair and regrow healthy heart tissue. Previously, surgeons have used synthetic or other permanent patches to repair tissue defects, but a new product is allowing repairs to damaged tissue without leaving synthetic or foreign materials in the patient’s body.

A medical device, CorMatrix ECM™, was cleared by the United States Food and Drug Administration (FDA) in 2005 for pericardial closure and in 2007 for cardiac tissue repair. CorMatrix ECM also received CE Marking for use in Europe in 2008 for pericardial closure.

About CorMatrix ECM
Extracellular matrix is a naturally occurring substance that helps regulate cells and is present in all humans and animals. A natural source to produce a manufactured extracellular matrix is derived from the thin lining of the small intestine of a pig. After it is harvested, the extracellular matrix is processed in a way that removes all cells. Only the complex structural matrix, which is made of collagen, remains. After sterilization and testing, CorMatrix ECM is an exceptionally strong, but very pliable and thin sheet that can be sewn onto the heart to facilitate the repair of different heart structures.

Once implanted, CorMatrix ECM acts as a scaffold into which the patient’s own cells migrate and integrate, stimulating the patient’s natural wound-healing mechanisms. The patient’s cells lay down their own collagen, developing a strong and permanent tissue repair without leaving behind a permanent foreign material.

How does Extracellular Matrix naturally repair cardiovascular tissue?
The cells in our bodies can only grow and multiply if they have some type of structure to which they can attach. This structural “bio-scaffold” within our bodies supports and encourages cell growth, which ultimately forms different types of tissue.

CorMatrix ECM is a unique bio-scaffold “patch” that, when sutured to the patient’s heart tissue during surgery, enables patients to naturally regrow their own cardiovascular tissue.

Once the ECM is surgically implanted, the patient’s own cells migrate and integrate, as part of the body’s innate wound-healing mechanisms to restore tissue at the site of implantation. During the tissue repair process, the matrix provides a framework for the patient’s own cells to attach and organize. The cells produce new matrix, replacing the implanted patch which is resorbed over time. This leaves remodeled, functional tissue instead of scar tissue or injured tissue.

What is the advantage of using ECM?
Synthetic materials and traditional surgical patches lack the performance characteristics of a tissue-based product and can cause an inflammatory response by the body. CorMatrix ECM, however, leads to the growth of new, functional cardiovascular tissue.

Are there any side effects to the procedure?
Extracellular matrix is a normal component of living tissue. No side effects attributable to extracellular matrix have been reported.

How many patients have received CorMatrix ECM?
An estimated 500,000 patients worldwide have been implanted with a manufactured extracellular matrix device for repairs done in all areas of the body. Nearly 20,000 CorMatrix ECM implants have been completed since the first product became commercially available for cardiovascular use in 2006.

How can I determine if I should have a CorMatrix ECM?
If you have been told you need open heart surgery, ask your surgeon if you could benefit from the use of CorMatrix ECM.