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Questions about Remodeling the Heart with Tissue Technology

What are these first-ever valve repair and remodeling procedures?
St. Francis Heart Center Chief of Cardiovascular and Thoracic Surgery Marc Gerdisch, M.D., has successfully performed the first-ever surgeries to repair or remodel internal heart structures using a unique bio-scaffold “patch.” Known as Extracellular Matrix, this unique patch is sutured to the patient’s heart tissue during surgery. Once implanted, the ECM serves as a bio-scaffold, allowing the patient’s own cardiovascular tissue to naturally re-grow over a period of several months. Over time, ECM is entirely replaced by the patient's own tissue.

What is Extracellular Matrix?
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.

Nearly 20,000 implants of CorMatrix ECM™ occurred since the first product was launched in 2006. Preclinical and clinical studies continue to look at new ways the unique CorMatrix ECM may advance the future of cardiovascular medicine. Future clinical studies will support further understanding of the value of CorMatrix ECM in addressing cardiovascular disease.

What are the benefits of using the ECM?
Animal tissue implants are subject to calcium deposition and hardening, due to the body’s ability to recognize them as foreign. Synthetic material lacks the performance characteristics of tissue and causes an inflammatory response. ECM, however, leads to the growth of new, functional cardiovascular tissue.

What is the ECM made of?
The ECM is derived from porcine small intestines and is processed in a way that removes all cells, leaving the complex structural matrix intact. 

How does it work?
An article in a 2008 issue of Circulation stated, “So without a doubt, no matter what type of cell or what organ it is, if the donor does not have a healthy matrix to adhere to, it simply won’t survive…” The ECM serves as that matrix for some patients requiring complex valve repair or replacement surgery.

Once the ECM is surgically implanted, the patient’s own cells migrate and integrate, stimulating the body’s innate wound-healing mechanisms to repair tissue at the site of implantation. During the tissue repair process, the matrix is degraded and resorbed, leaving remodeled functional tissue.

How is the ECM used?
The ECM is an exceptionally strong fibrous sheet that becomes very pliable when hydrated. It is cut to the appropriate dimensions by Dr. Gerdisch, and then sewn in with fine suture to repair or remodel the interior cardiac structure. The ECM serves as an interim bio-scaffold as the tissue is regrown.

Once the ECM is surgically implanted, the patient’s own cells migrate and integrate, stimulating the body’s innate wound-healing mechanisms to repair tissue at the site of implantation. During the tissue repair process, the matrix is degraded and resorbed, leaving the remodeled functional tissue.

When did Dr. Marc Gerdisch perform his groundbreaking surgeries?
In 2007, Dr. Gerdisch became the first in the world to apply this technology inside the heart, successfully repairing a congenital abnormality. This patient continues to do very well. Then, in 2008, he conducted the first-ever aortic annular and root enlargement using the ECM. The patient was discharged POD 4 and was Functional Class 1. Thirty weeks post-op, a CT angiogram of the aorta demonstrated no evidence of the ECM patch. Later the same year, Dr. Gerdisch performed the first repair of a damaged mitral valve, placing two patches to replace injured tissue and avoid replacing the valve.

For how many patients has Dr. Gerdisch performed this procedure?
Since August 2007, Dr. Gerdisch has helped more than 40 patients reconstruct their damaged cardiac tissue with this surgical procedure, which allows for natural tissue regrowth and remodeling. 

Why did Dr. Gerdisch explore this new procedure?
To avoid leaving patients with a foreign body inside their hearts, Dr. Gerdisch uses this remarkable bio-scaffold in various configurations to augment and repair the heart and its valves. The surgery using the ECM, coupled with the body’s innate ability to repair damaged heart tissue, offers significant healing advantages and quality of life benefits to patients after surgery.

When was the ECM first introduced?
First introduced in 2006, the ECM was originally used to repair the pericardium following open heart surgery. With the ECM, patients naturally re-grew this protective layer to close the pericardial incision.

How many people have received an ECM implant?
An estimated 500,000 patients worldwide have received an ECM implant, but Dr. Gerdisch and the St. Francis Heart Center were the first to use the ECM to repair and rebuild internal heart structures.

Who is a good candidate for this procedure?
The ECM valve surgery, like other valve repair or replacement surgery options, is one treatment option for patients with heart valve disease The St. Francis Heart Center recommends that patients consult with their primary care or cardiovascular physicians to gain more information about cardiovascular and valve repair surgeries.

What is the recovery period for this procedure?
The recovery period depends on the individual patient. However, follow-up diagnostics have demonstrated excellent structural integrity and performance for the remodeled tissue.

For which procedures is the ECM licensed?
CorMatrix Cardiovascular holds an exclusive license from Purdue University to research, develop, manufacture and market naturally occurring ECM products for cardiovascular applications. The company currently has a U.S. clearance and European approval with a CE Mark for its ECM Technology as an implant for pericardial closure and clearance in the U.S. for use in cardiac tissue repair.

Is the ECM used in other surgical procedures?
The ECM also is used in non-cardiovascular applications for soft tissue repair, wound management and orthopaedic applications.

Who is Dr. Marc Gerdisch?
Marc Gerdisch, M.D.is the chief of cardiovascular and thoracic surgery at the St. Francis Heart Center located at Franciscan St. Francis Health in Indianapolis. He is also the surgical director of the St. Francis Heart Valve Center. Dr. Gerdisch is an independent physician, who chooses to practice at Franciscan St. Francis Health.

Does Dr. Gerdisch plan to share this protocol with other medical institutions?
Dr. Gerdisch recently presented his early experience at the international meeting of The Society of Heart Valve Disease in Berlin. He is happy to share his insight into the use of ECM for cardiac reconstruction with all interested physicians and institutions.

Has Dr. Gerdisch published a paper on this procedure?
Paper are currently going through the peer review process. Information will be updated on this site as soon as the paper has been approved.