CorMatrix, an Atlanta, Georgia company, has received FDA approval to use its CorMatrix ECM™ material during cardiac procedures for “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”, according to a company representative. Additionally, CorMatrix received EU’s CE Mark for its CorMatrix ECM for Pericardial Closure bioscaffold and plans on marketing the material in Europe this year.
From a press release obtained by Medgadget:
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 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 this 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 over time to form a functional tissue repair. The implanted ECM material is gradually replaced and resorbed by the body as the patient’s tissue is remodeled.