On January 10, 2002, the Orthopaedics and Rehabilitation Devices Panel met to discuss and make recommendations for PMA P000058, InFUSE Bone Graft (rhBMP-2/ACS)/LT Cage.
The committee was formed by the following members: Maureen Finnegan, M.D., (acting chairperson), Sally Maher, ESQ. (Industry Representative), Karen Rue (Consumer Representative), Stephen Li, Ph.D., Edward Hanley, M.D., Sanjiv Naidu, M.D., Ph.D., Leon Lenchik, M.D., Gene Siegal, M.D., Ph.D., John, Kirkpatrick, M.D., Barbara Boyan, M.D., John Doull, Ph.D., Betty Diamond, M.D., Rocky Tuan, Ph.D. (guest), John Kostuik, M.D. (guest), Hari Reddi, Ph.D., Richard Miller, Ph.D., (guest), Kinley Larntz, Ph.D. Please note that Dr. Edward Hanley was not allowed to vote because of his limited waiver.
The panel made the following recommendation:
The panel voted 9-0 for approval with conditions. The conditions were as follows:
1) Study anti-RhBMP 2 in systemic administration mouse model for antibodies at conception, implantation, limb bud formation time points.
2) Study mouse model with equal dosing and multiple dosing of rhBMP-2 over long time to complement the large dose at single time.
3) Assess the potential for BMP-2 to promote growth of primary tumor isolates which have been
analyzed for BMP-2 receptor expression.
4) BMP only approved for use with tapered cages.
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