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

Dr. Marshall Urist Dr. Marshall Urist Bone Morphogenetic ProteinsBone Morphogenetic Proteins

19651965

Recombinant Bone Recombinant Bone Morphogenetic Protein - 2 Morphogenetic Protein - 2

(rhBMP-2)(rhBMP-2)

Manufactured by Manufactured by Wyeth-Genetics InstituteWyeth-Genetics Institute

Absorbable Collagen Sponge Absorbable Collagen Sponge (ACS)(ACS)

Manufactured by Manufactured by Integra Life Sciences Integra Life Sciences

rhBMP-2 + ACS =rhBMP-2 + ACS =

InFUSE™ Bone GraftInFUSE™ Bone Graft

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

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

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

PMA P000058PMA P000058

InFUSE™Bone Graft / LT-CAGE™DeviceInFUSE™Bone Graft / LT-CAGE™DeviceFDA Panel PresentationsFDA Panel Presentations

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