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

1 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

2 Dr. Marshall Urist Bone Morphogenetic Proteins 1965

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

4

5 Absorbable Collagen Sponge (ACS) Manufactured by Integra Life Sciences

6 rhBMP-2 + ACS = InFUSE™ Bone Graft

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11 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

12 InFUSE™Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device G960065 Prospective, Randomized, Controlled Multi-centered Clinical Trial

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

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

15 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

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