CorMatrix Announces FDA 510(k) for Novel Biomaterial Implant for Intracardiac Repair
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.
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 also announced it received CE Mark approval in the first quarter for the CorMatrix ECM for Pericardial Closure and anticipates launching this product in Europe and other international markets later this 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 provide an important advancement for cardiac surgeons and their patients," said Beecher Lewis, President and COO of CorMatrix. "Because our ECM Technology supports native tissue repair, it represents a significant advancement over currently available materials."
About Extracellular Matrix Biomaterial
The unique properties of extracellular matrix biomaterials were discovered at Purdue University. The decellularized matrix material serves as a scaffold to allow adjacent tissues to deliver cells and nutrients to the matrix, which then differentiate into tissue-specific cells. The ECM material is gradually replaced, as the patient's own body reinforces and rebuilds the weakened site. During the repair the matrix is rapidly degraded and resorbed, leaving remodeled functional tissue where scar tissue or injured tissue would normally be expected.
The use of extracellular matrix materials in non-cardiovascular applications has established a significant foothold in soft tissue repair, wound management and orthopedic applications. The safety of extracellular matrices has been well established in a number of different clinical applications. The extracellular matrix has been studied extensively, with more than 500 published papers. Since 1999, an estimated 500,000 patients worldwide have received an extracellular matrix implant.
About CorMatrix ECM Technology(TM)
CorMatrix Cardiovascular holds an exclusive license from Purdue University to research, develop, manufacture and market naturally occurring extracellular matrix products for cardiovascular applications. CorMatrix is currently conducting a number of preclinical studies utilizing the ECM Technology for a variety of cardiovascular applications. The company has U.S. and European clearance to market the CorMatrix ECM Technology(TM) as an implant for pericardial closure and clearance in the U.S. for cardiac tissue repair. CorMatrix ECM Technology is used at more than 160 hospitals across the U.S. and has been implanted during more than 4,000 cardiac procedures.
The CorMatrix ECM Technology platform utilizes a naturally occurring extracellular matrix biomaterial that is harvested from porcine small intestine submucosa. To transform the raw extracellular matrix material into the CorMatrix ECM Technology, the matrix is processed to remove cells, effectively eliminating any immune rejection.
About CorMatrix Cardiovascular, Inc.
CorMatrix Cardiovascular, a privately held company based in Atlanta, Georgia, is dedicated to developing and delivering innovative biomaterial devices that harness the body's innate ability to repair damaged cardiovascular structures. For more information, visit http://www.cormatrix.com.
Source: CorMatrix Cardiovascular, Inc.