Page 1
InFUSEInFUSE™™ Bone Graft / Bone Graft /LT-CAGE LT-CAGE ™ ™ Lumbar Tapered Lumbar Tapered
Fusion DeviceFusion Device
Orthopedic and RehabilitationOrthopedic and RehabilitationDevice Advisory Panel PresentationDevice Advisory Panel Presentation
Bailey Lipscomb, Ph.D.Bailey Lipscomb, Ph.D.Vice President, Clinical AffairsVice President, Clinical Affairs
Medtronic Sofamor DanekMedtronic Sofamor Danek
Page 2
Dr. Marshall Urist Dr. Marshall Urist Bone Morphogenetic ProteinsBone Morphogenetic Proteins
19651965
Page 3
Recombinant Bone Recombinant Bone Morphogenetic Protein - 2 Morphogenetic Protein - 2
(rhBMP-2)(rhBMP-2)
Manufactured by Manufactured by Wyeth-Genetics InstituteWyeth-Genetics Institute
Page 5
Absorbable Collagen Sponge Absorbable Collagen Sponge (ACS)(ACS)
Manufactured by Manufactured by Integra Life Sciences Integra Life Sciences
Page 6
rhBMP-2 + ACS =rhBMP-2 + ACS =
InFUSE™ Bone GraftInFUSE™ Bone Graft
Page 11
What is the Issue Today?What is the Issue Today? NotNot LT-CAGE™ Lumbar Tapered LT-CAGE™ Lumbar Tapered
Fusion Device - FDA APPROVEDFusion Device - FDA APPROVED
NotNot Absorbable Collagen Sponge - Absorbable Collagen Sponge - FDA APPROVED FDA APPROVED
InFUSE™ Bone Graft as Replacement InFUSE™ Bone Graft as Replacement for Bone Graftfor Bone Graft
Page 12
InFUSE™Bone Graft / LT-CAGE™InFUSE™Bone Graft / LT-CAGE™Lumbar Tapered Fusion Device Lumbar Tapered Fusion Device
G960065G960065
Prospective, Randomized,Prospective, Randomized,Controlled Multi-centered Controlled Multi-centered
Clinical TrialClinical Trial
Page 13
InFUSE™Bone Graft / LT-CAGE™InFUSE™Bone Graft / LT-CAGE™Lumbar Tapered Fusion Device Lumbar Tapered Fusion Device
PMA P000058PMA P000058
Page 14
InFUSE™Bone Graft / LT-CAGE™DeviceInFUSE™Bone Graft / LT-CAGE™DeviceFDA Panel PresentationsFDA Panel Presentations
Page 15
Additional ResourcesAdditional Resources Kenneth Burkus, M.D.Kenneth Burkus, M.D.
Thomas Zdeblick, M.D.Thomas Zdeblick, M.D.
Charles Branch, M.D.Charles Branch, M.D.
David Polly, M.D.David Polly, M.D.
Vin Sandhu, M.D.Vin Sandhu, M.D.
Richard Herzog, M.D.Richard Herzog, M.D.
Harry Genant, M.D.Harry Genant, M.D.
David Trentham, M.D.David Trentham, M.D.
Breck Collins, M.D.Breck Collins, M.D.
Donald Berry, Ph.D.Donald Berry, Ph.D.
Jeffrey Toth, Ph.D.Jeffrey Toth, Ph.D.
Larry BoydLarry Boyd
John Wozney, Ph.D.John Wozney, Ph.D.
Wyeth-Genetics Institute StaffWyeth-Genetics Institute Staff
Medtronic Sofamor Danek Medtronic Sofamor Danek StaffStaff