VIRGINIA BEACH, Va., Nov. 3 LifeNet Health, a leading allograft bio-implant company, announces it has received 510(K) clearance from the United States Food and Drug Administration (FDA) for CardioGraft(R) allograft cardiac patch products with MatrACELL(TM) decellularization technology.
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LifeNet Health received clearance for the technology for cardiac products, which safely removes donor cells from cardiovascular tissues while retaining the native biomechanical strength of the tissue.
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"This clearance further strengthens LifeNet Health's global leadership position in the pediatric cardiac reconstruction market," said Rony Thomas, LifeNet Health President and CEO. "We are looking forward to working with pediatric centers around the world to help save lives and restore health."
LifeNet Health, founded in 1982, is a full service biomedical tissue banking system and a leading non-profit organ and tissue donation agency whose mission is saving lives and restoring health. Known for its outstanding safety record and its unyielding commitment to quality, LifeNet Health provides recovery and processing services for musculoskeletal and cardiovascular tissues, distributing more than 250,000 biomedical implants every year to restore health to patients around the world.
For additional information about LifeNet Health, visit http://www.lifenethealth.org.
CONTACT: Dena Reynolds of LifeNet Health, +1-800-847-7831, [email protected]
SOURCE LifeNet Health
