InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device Orthopedic and Rehabilitation Device Advisory Panel Presentation Bailey Lipscomb, Ph.D. Vice.

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Presentation transcript:

InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device Orthopedic and Rehabilitation Device Advisory Panel Presentation Bailey Lipscomb, Ph.D. Vice President, Clinical Affairs Medtronic Sofamor Danek

Dr. Marshall Urist Bone Morphogenetic Proteins 1965

Recombinant Bone Morphogenetic Protein - 2 (rhBMP-2) Manufactured by Wyeth-Genetics Institute

Absorbable Collagen Sponge (ACS) Manufactured by Integra Life Sciences

rhBMP-2 + ACS = InFUSE™ Bone Graft

What is the Issue Today? n Not LT-CAGE™ Lumbar Tapered Fusion Device - FDA APPROVED n Not Absorbable Collagen Sponge - FDA APPROVED n InFUSE™ Bone Graft as Replacement for Bone Graft

InFUSE™Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device G Prospective, Randomized, Controlled Multi-centered Clinical Trial

InFUSE™Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device PMA P000058

InFUSE™Bone Graft / LT-CAGE™Device FDA Panel Presentations InFUSE™Bone Graft / LT-CAGE™Device FDA Panel Presentations

Additional Resources n Kenneth Burkus, M.D. n Thomas Zdeblick, M.D. n Charles Branch, M.D. n David Polly, M.D. n Vin Sandhu, M.D. n Richard Herzog, M.D. n Harry Genant, M.D. n David Trentham, M.D. n Breck Collins, M.D. n Donald Berry, Ph.D. n Jeffrey Toth, Ph.D. n Larry Boyd n John Wozney, Ph.D. n Wyeth-Genetics Institute Staff n Medtronic Sofamor Danek Staff