Presentation is loading. Please wait.

Presentation is loading. Please wait.

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

Published byBarnaby Page Modified over 9 years ago

Similar presentations

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

7

8

9

10

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

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

Similar presentations

Parallel Session 1 The Role of the Statistician in Post- Marketing, Including Surveillance Organizers –Harry Bushar (FDA-CDRH) –Greg Campbell (FDA-CDRH)

Parallel Session 1 The Role of the Statistician in Post- Marketing, Including Surveillance Organizers –Harry Bushar (FDA-CDRH) –Greg Campbell (FDA-CDRH)
Results of the Prospective, Randomized, Multicenter FDA Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Versus Circumferential.

Results of the Prospective, Randomized, Multicenter FDA Investigational Device Exemption Study of the ProDisc-L Total Disc Replacement Versus Circumferential.
rhBMP-2: origin, biology and preclinical safety

rhBMP-2: origin, biology and preclinical safety
Summary of InFUSE ™ Bone Graft Preclinical and Pilot Clinical Studies with Interbody Spinal Fusion Devices Scott Boden, M.D. Professor of Orthopaedic Surgery.

Summary of InFUSE ™ Bone Graft Preclinical and Pilot Clinical Studies with Interbody Spinal Fusion Devices Scott Boden, M.D. Professor of Orthopaedic Surgery.
E-Poster #510 Mineralized Collagen and Bone Marrow Aspirate in Anterior Interbody Carbon Fiber Cages Achieve High Fusion Rates in Multilevel Adult Spinal.

E-Poster #510 Mineralized Collagen and Bone Marrow Aspirate in Anterior Interbody Carbon Fiber Cages Achieve High Fusion Rates in Multilevel Adult Spinal.
A-1 Pravastatin-Aspirin Introduction Todd Baumgartner, MD, MPH Vice President Regulatory Sciences Pharmaceutical Research Institute Bristol-Myers Squibb.

A-1 Pravastatin-Aspirin Introduction Todd Baumgartner, MD, MPH Vice President Regulatory Sciences Pharmaceutical Research Institute Bristol-Myers Squibb.
AGGRENOX TM Advisory Committee Meeting. Manfred Haehl, MD Senior Vice President, Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals,

AGGRENOX TM Advisory Committee Meeting. Manfred Haehl, MD Senior Vice President, Medical & Drug Regulatory Affairs Boehringer Ingelheim Pharmaceuticals,
Effects of BMP-2 and -7 on Oral Squamous Carcinoma Cells 1 University of Michigan School of Dentistry, Ann Arbor, Michigan, USA; 2 Washington University.

Effects of BMP-2 and -7 on Oral Squamous Carcinoma Cells 1 University of Michigan School of Dentistry, Ann Arbor, Michigan, USA; 2 Washington University.
Scaffolds, Growth Factors, and Tissue Constructs Hasan Uludag Department of Chemical & Materials Engineering, Department of Biomedical Engineering, and.

Scaffolds, Growth Factors, and Tissue Constructs Hasan Uludag Department of Chemical & Materials Engineering, Department of Biomedical Engineering, and.
Office of Cellular Tissue and Gene Therapies Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies Cellular, Tissue, and.

Office of Cellular Tissue and Gene Therapies Celia M.Witten, Ph.D., M.D. Director, Office of Cellular, Tissue, and Gene Therapies Cellular, Tissue, and.
InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G960065 Hallett H. Mathews, M.D. Richmond, Virginia.

InFUSE ™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G Hallett H. Mathews, M.D. Richmond, Virginia.
1 DJ5895D A CLINICAL REVIEW OF CERVICAL AND LUMBAR ARTHROPLASTY.

1 DJ5895D A CLINICAL REVIEW OF CERVICAL AND LUMBAR ARTHROPLASTY.
Bone Morphogenetic Protein By: Kim Stephens. What is Bone Morphogenetic Protein? Stimulates a patient's own cells to induce the formation of bone and.

Bone Morphogenetic Protein By: Kim Stephens. What is Bone Morphogenetic Protein? Stimulates a patient's own cells to induce the formation of bone and.
Recombinant Human Bone Morphogenetic Protein-2 for Treatment of Open Tibial Fractures by, Shunmugam Govender, Cristina Csimma, Harry K. Genant, Alexandre.

Recombinant Human Bone Morphogenetic Protein-2 for Treatment of Open Tibial Fractures by, Shunmugam Govender, Cristina Csimma, Harry K. Genant, Alexandre.
Application of Bone Morphogenetic Proteins in the Treatment of Clinical Oral and Maxillofacial Osseous Defects by Philip J. Boyne J Bone Joint Surg Am.

Application of Bone Morphogenetic Proteins in the Treatment of Clinical Oral and Maxillofacial Osseous Defects by Philip J. Boyne J Bone Joint Surg Am.
1 Telba Irony, Ph.D. Mathematical Statistician Division of Biostatistics Statistical Analysis of InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device.

1 Telba Irony, Ph.D. Mathematical Statistician Division of Biostatistics Statistical Analysis of InFUSE  Bone Graft/LT-Cage Lumbar Tapered Fusion Device.
DuraSealTM Dural Sealant System PMA P040034

DuraSealTM Dural Sealant System PMA P040034
CH. 15-2 THE EXECUTIVE OFFICE OF THE PRESIDENT ADVANCED AMERICAN GOVERNMENT.

CH THE EXECUTIVE OFFICE OF THE PRESIDENT ADVANCED AMERICAN GOVERNMENT.
THE GRADUATE PROGRAM IN Orthopaedic Regulatory & Clinical Affairs (ORCA)

THE GRADUATE PROGRAM IN Orthopaedic Regulatory & Clinical Affairs (ORCA)
1SpineMatrix. Product 2 SMI has developed the Lumbar Matrix System A unique spinal physiology imaging scan used to diagnose disc, facet and chronic LBP.

1SpineMatrix. Product 2 SMI has developed the Lumbar Matrix System A unique spinal physiology imaging scan used to diagnose disc, facet and chronic LBP.

Similar presentations

Ads by Google