, Oct. 12, 2011
/PRNewswire/ -- CorMatrix Cardiovascular, Inc., a medical device company dedicated to developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardio-vascular tissue, announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its CorMatrix® ECM® for Carotid Repair, which utilizes the company's proprietary ECM Technology.
The company's platform ECM Technology, an extracellular matrix biomaterial which provides a natural bio-scaffold enabling a patient's own host cells to repopulate and repair damaged tissues, is currently FDA cleared for pericardial closure and cardiac tissue repair. This recent 510(k) clearance adds to the CorMatrix product line with a new design and indication for vascular reconstruction and repair of the carotid artery, including patch closure following endarterectomy and suture line buttressing.
"The peripheral vascular surgery community is quite familiar with the use of the CorMatrix Technology by cardiac surgeons for pericardial reconstruction and cardiovascular repair. We are excited to have a unique CorMatrix material, with several potentially advantageous properties, now available for use in carotid endarterectomy, " said W. Darrin Clouse, MD, FACS, Director, Northern California Federal Vascular Surgery.
The CorMatrix material is a naturally occurring bio-scaffold, which has been used at more than 500 hospitals across the U.S. and successfully implanted in over 40,000 patients. The unique CorMatrix material helps stimulate tissue growth by providing a location where the patient's cells can migrate and integrate, eventually creating new tissue in place of the CorMatrix ECM.
"We believe the unique properties of our CorMatrix material provide a new and vital alternative to current approaches in carotid artery repair. Having received numerous inquires from the clinical surgery community for a CorMatrix product to address this clinical need, we were very pleased with the timely manner in which FDA reviewed and cleared this submission." stated David Camp, Chairman & CEO of CorMatrix.
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 CorMatrix implant is gradually replaced, as the patient's own body reinforces and rebuilds the weakened site. During the repair, the matrix is naturally 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, over a million patients worldwide have received an extracellular matrix implant.
About CorMatrix ECM Technology
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 U.S. clearance and European approval with a CE Mark for its ECM Technology as an implant for pericardial closure and for use in cardiac tissue repair.
About CorMatrix Cardiovascular, Inc.
CorMatrix Cardiovascular, a privately held company based in Atlanta, Georgia, is dedicated to developing and delivering innovative cardiovascular devices that harness the body's innate ability to remodel damaged tissue. For more information, visit www.cormatrix.com.
SOURCE CorMatrix Cardiovascular, Inc.