Integra LifeSciences Announces FDA Clearance for New Indication for Accell Evo3 Demineralized Bone Matrix

Integra LifeSciences Holdings Corporation IART today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market Accell Evo3(R) Demineralized Bone Matrix as a bone void filler product for use in the posterolateral spine. In a pivotal animal study, Accell Evo3(R) Demineralized Bone Matrix demonstrated effective bone formation and achieved bilateral fusion at 12 weeks, when tested in the posterolateral rabbit spine model. Radiographic, histologic and biomechanical analyses showed that Accell Evo3(R) Demineralized Bone Matrix performed as well as autograft, which served as the basis for the Pre-Market Notification decision.