New biologic bone graft product demonstrated superior fusion rates compared to current standard of care for complex fusion procedures of the lower spine in the pivotal clinical trial.
MINNEAPOLIS–(HSMN NewsFeed)–The U.S. Food and Drug Administration (FDA) Orthopaedic and Rehabilitation Devices Panel today voted 9 for and 4 against (1 abstention) on safety and 10 for and 3 against (1 abstention) on effectiveness, that data including results from a large, prospective randomized clinical trial demonstrated the safety and effectiveness of AMPLIFY™ rhBMP-2 Matrix for fusions of the lower spine in patients with degenerative disc disease. The benefits of this new bone graft option, which is specifically designed for single-level, posterolateral spinal fusion procedures, were also found by a majority of those voting to outweigh any risks associated with this product by a vote of 6 for and 5 against (3 abstention). More »







WARSAW, Ind., July 22, 2010 /PRNewswire via COMTEX News Network/ –
KALAMAZOO, Mich., July 20, 2010 /PRNewswire via COMTEX/ –