Opportunities in European Spinal Product Markets
Published January 2001 | 616 Pages | 147 Exhibits | Forecasts Through 2005
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Overview
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Companies Covered
B. Braun Melsungen AG (Aesculap)
Biolectron
Biomet/EBI
Clarus Medical Systems
Computer Motion
Corin Group Limited
Cremascoli Ortho Group
Endius Inc
Implex Corporation
Integrated Surgical Systems
Intuitive Surgical
IsoTis NV
Johnson & Johnson (DePuy AcroMed, Codman & Shurtleff)
Kyphon Inc
Medtronic Sofamor Danek
ORATEC Interventions Inc.
Orthofix International
Orthologic
Orthovita
Osteotech
Raymedica Inc
Scient'X
Smith & Nephew plc (Dyonics, Exogen)
Stryker Corporation (Howmedica Osteonics)
Sulzer Medica Ltd
Synthes-Stratec
Tutogen Medical Inc
Tyco International Ltd. (Surgical Dynamics)
Waldemar Link GmbH & Company
Wright Medical Corporation
Table of Contents
EXECUTIVE SUMMARY
Spinal Instrumentation
Bone Graft Substitutes and Growth Factors
Fusion Alternatives
Vertebral Fracture Management
Other Products
Exhibit ES-1: European Spinal Products Market by Major Product Group, 1998-2005
Exhibit ES-2: European Spinal Products Market by Country, 1998-2005
Exhibit ES-3: European Market for Spinal Instrumentation, 1998-2005
Exhibit ES-4: European Market for Bone Graft and Growth Factors, 1998-2005
Exhibit ES-5: European Market for Fusion Alternatives, 1998-2005
Exhibit ES-6: European Market for Vertebral Fracture Products, 1998-2005
Exhibit ES-7: European Market for Other Spine Products, 1998-2005
1.0 OVERVIEW OF SPINAL DISORDERS
1.1 Anatomy of the Human Spine
1.1.1 Bone Physiology and Remodeling
1.1.2 Vertebrae
1.1.3 Intervertebral Discs
1.1.4 Spinal Cord
1.2 Spinal Conditions
1.2.1 Degenerative Disorders
1.2.1.1 Degenerative Disc Disease
1.2.1.1.1 Prevalence
1.2.1.1.2 Symptoms and Diagnosis
1.2.1.1.3 Treatment
1.2.1.2 Herniated Disc
1.2.1.2.1 Types
1.2.1.2.2 Symptoms and Diagnosis
1.2.1.2.3 Prevalence
1.2.1.2.4 Treatment
1.2.1.3 Spinal Stenosis
1.2.1.3.1 Symptoms and Diagnosis
1.2.1.3.2 Prevalence
1.2.1.3.3 Treatment
1.2.1.4 Spondylosis
1.2.1.4.1 Prevalence
1.2.1.4.2 Symptoms and Diagnosis
1.2.1.4.3 Treatment
1.2.1.5 Spondylolisthesis
1.2.1.5.1 Prevalence
1.2.1.5.2 Types
1.2.1.5.3 Diagnosis
1.2.1.5.4 Treatment
1.2.1.6 Osteoporosis
1.2.1.6.1 Fracture Prevalence
1.2.1.6.2 Types
1.2.1.6.3 Risk Factors
1.2.1.6.4 Diagnosis
1.2.1.6.5 Treatment
1.2.1.7 Osteoarthritis
1.2.1.7.1 Prevalence
1.2.1.7.2 Risk Factors
1.2.1.7.3 Diagnosis
1.2.1.7.4 Treatment
1.2.1.8 Rheumatoid Arthritis
1.2.2 Spinal Trauma
1.2.2.1 Cervical, Thoracic and Lumbar Trauma
1.2.2.2 Spinal Cord Trauma
1.2.3 Deformity Disorders
1.2.3.1 Scoliosis
1.2.3.1.1 Symptoms
1.2.3.1.2 Diagnosis
1.2.3.1.3 Treatment
1.2.3.2 Kyphosis
1.2.3.2.1 Symptoms
1.2.3.2.2 Diagnosis
1.2.3.2.3 Treatment
1.2.3.3 Lordosis
1.2.4 Spinal Tumors
1.2.4.1 Malignant Spinal Tumors
1.2.4.2 Spinal Hemangiomas
Exhibit 1-1: Structure of the Vertebrae
Exhibit 1-2: The Spine
Exhibit 1-3: Prolapsed Intervertebral Disc
Exhibit 1-4: Overview of Spine Conditions
Exhibit 1-5: Types of Spondylolisthesis
Exhibit 1-6: Overview of Osteoporosis
Exhibit 1-7: Comparison of Osteoarthritis and Rheumatoid Arthritis
Exhibit 1-8: Spinal Trauma
Exhibit 1-9: Comparison of Spinal Deformity Disorders
Exhibit 1-10: Cancers With High Probability of Metastasizing to Spine, 1996
2.0 SPINAL STABILIZATION AND FUSION
2.1 Clinical Goals and Outcomes
2.1.1 Failure of Fusion
2.1.2 Failure of Pain Relief
2.2 Classification of Spinal Fusions
2.2.1 Spine Segments Fused
2.2.2 Levels Fused
2.2.3 Use of Instrumentation and Cages
2.2.4 Surgical Approaches
2.2.4 Access Method
2.3 Specialists Performing Spine Surgery
2.4 Spinal Fusions by Segment and Instrumentation
2.4.1 Cervical Spine
2.4.1.1 Surgical Approaches to Cervical Spine
2.4.1.1.1 Anterior Cervical Plating
2.4.1.1.2 Posterior Approach
2.4.1.1.3 Posterolateral Approach
2.4.1.1.4 360o Circumferential Approach
2.4.1.2 Cervical Instrumentation
2.4.1.3 Procedures
2.4.2 Thoracolumbar Spine
2.4.2.1 Surgical Approaches to Thoracolumbar Spine
2.4.2.1.1 Anterior Approach
2.4.2.1.2 Posterior Approach
2.4.2.2 Thoracolumbar Instrumentation
2.4.2.2.1 Anterior Instrumentation
2.4.2.2.2 Posterior Instrumentation
2.4.2.3 Procedure Forecast
2.5 Traditional Instrumentation Systems
2.5.1 Product Configurations
2.5.1.1 Hook/Screw and Rod Systems
2.5.1.2 Plate Systems
2.5.1.3. Wires and Clamps
2.5.2 Products and Suppliers by Segment
2.5.2.1 Thoracolumbar Instrumentation
2.5.2.1.1 Depuy AcroMed
2.5.2.1.2 EBI/Biomet
2.5.2.1.3 Interpore Cross International
2.5.2.1.4 Scient' X
2.5.2.1.5 Sofamor Danek (Medtronic)
2.5.2.1.6 Sulzer Spine-Tech
2.5.2.1.7 Stryker Howmedica
2.5.2.1.8 Surgical Dynamics
2.5.2.1.9 Synthes-Stratec
2.5.2.2 Cervical Instrumentation
2.5.2.2.1 Aesculap
2.5.2.2.2 Depuy AcroMed
2.5.2.2.3 EBI/Biomet
2.5.2.2.4 Scient' X
2.5.2.2.5 Sofamor Danek
2.5.2.2.6 Synthes-Stratec
2.5.3 Dynamic Fixation/Neutralization
2.5.3.1 Eurosurgical
2.5.3.2 Sulzer Orthopedics
2.5.3.2.1 Product Description
2.5.3.2.2 Implantation
2.5.3.2.3 Benefits
2.5.3.2.4 Indications
2.5.3.2.5 Clinical Outcomes
2.5.3.3 Mekanika
2.5.4 Other Product Developments
2.5.5 Procedure Forecast
2.5.6 Market Analysis
2.5.6.1 Cervical Instrumentation Systems
2.5.6.2 Thoracolumbar Instrumentation Systems
2.5.7 Supplier Shares
2.6 Interbody Fusion Devices
2.6.1 Performance Criteria and Goals
2.6.2 Materials
2.6.3 Cage Designs
2.6.3.1 Cylindrical Cages
2.6.3.2 Oval Cages
2.6.3.3 Rectangular Cages
2.6.4 Implantation Technique
2.6.4.1 Anterior Lumbar Interbody Fusion
2.6.4.2 Posterior Lumbar Interbody Fusion
2.6.4.3 Transforaminal Lumbar Interbody Fusion
2.6.5 Failure of Interbody Fusion Devices
2.6.6 Products and Suppliers
2.6.6.1 Advanced Spine Fixation Systems
2.6.6.2 Aesculap
2.6.6.3 Co-Ligne AG
2.6.6.4 Corin Spinal Systems
2.6.6.5 DePuy AcroMed
2.6.6.5.1 Lumbar I/F
2.6.6.5.2 Surgical Titanium Mesh
2.6.6.6 Eurosurgical
2.6.6.6.1 Thesis
2.6.6.6.2 AMSLU Cage
2.6.6.7 GM Reis Spine
2.6.6.7.1 Rounded Bone Fusion Mesh
2.6.6.7.2 Lumbar Fuser IBF Screw
2.6.6.7.3 Cervical Fuser IBF Screw:
2.6.6.8 Implex
2.6.6.9 Medinorm AG
2.6.6.10 PHUSIS
2.6.6.11 Scient' X
2.6.6.12 Signus Medizintechnik GmbH
2.6.6.13 Sofamor Danek (Medtronic)
2.6.6.13.1 Inter Fix
2.6.6.13.2 Inter Fix RP
2.6.6.13.3 Inter Fix C
2.6.6.13.4 Lordotec Interbody Fusion Device
2.6.6.13.5 Incline Series
2.6.6.13.6 Pyramesh Titanium Mesh
2.6.6.13.7 Telamon
2.6.6.13.8 Union
2.6.6.13.9 Cornerstone SR
2.6.6.14 Spinal Concepts
2.6.6.15 Spinal Innovations
2.6.6.16 The Spineology Group
2.6.6.17 Stellar Medical
2.6.6.18 Sulzer Spine-Tech
2.6.6.18.1 BAK Interbody Fusion System
2.6.6.18.2 BAK Proximity
2.6.6.18.3 BAK/C Cervical Cage
2.6.6.19 Surgical Dynamics
2.6.6.20 Surgicraft Limited (Hartshill Horseshoe)
2.6.6.21 Synthes-Stratec
2.6.6.21.1 Titanium Interbody Spacer
2.6.6.21.2 SynCage
2.6.6.21.3 Contact Fusion Cage
2.6.6.21.4 SynCage C
2.6.7 Procedure Forecast
2.6.8 Market Analysis
2.6.9 Supplier Shares
2.7 Bone Dowels and Wedges
2.7.1 Benefits and Limitations
2.7.2 Clinical Experience
2.7.3 Materials Supply
2.7.4 Implantation
2.7.5 Products
2.7.5.1 Cortek
2.7.5.2 DePuy AcroMed
2.7.5.3 Orthovita
2.7.5.4 Osteotech
2.7.5.5 Sofamor Danek/Regeneration Technologies
2.7.5.6 Synthes-Stratec
2.7.5.7 Tutogen Medical
2.7.6 Procedures
2.7.7 Market Analysis
2.7.8 Supplier Shares
2.8 Endoscopic Spinal Surgery Systems
2.8.1 Products
2.8.1.1 Endius
2.8.1.1.1 Instrumentation
2.8.1.1.2 Procedure
2.8.1.1.3 Clinical Experience
2.8.1.2 Sofamor Danek
2.8.1.2.1 Instrumentation
2.8.1.2.2 Procedure
2.8.1.2.3 Clinical Results
2.8.1.2.4 Procedure Trends
2.8.2 Procedure Forecast
2.8.3 Market Analysis
Exhibit 2-1: Methods of Categorizing Spinal Fusion Procedures
Exhibit 2-2: Surgical Approaches for Spinal Fusion
Exhibit 2-3: Spinal Fusions by Segment, Procedure Forecast, 1998-2005
Exhibit 2-4: Spinal Fusions by Country, Procedure Forecast, 1998-2005
Exhibit 2-5: Fusion Procedures by Surgical Approach, 1999 & 2005
Exhibit 2-6: Instrumented Fusions by Segment, 1998-2005
Exhibit 2-7: Cervical Fusions, Procedure Forecast by Instrumentation, 1998-2005
Exhibit 2-8: Total and Instrumented Cervical Fusions by Country, 1998-2005
Exhibit 2-9: Thoracolumbar Fusions by Instruments, Procedure Forecast, 1998-2005
Exhibit 2-10: Total and Instrumented Thoracolumbar Fusions by Country, 1998-2005
Exhibit 2-11: Traditional Instrumentation Product Configurations
Exhibit 2-12: Selected Thoracolumbar Spine Systems, 2000
Exhibit 2-13: Selected Cervical Spine Systems, 2000
Exhibit 2-14: Spinal Fusions Using Traditional Instrumentation, Procedure Forecast, 1998-2005
Exhibit 2-15: Cervical Fusions Using Traditional Instrumentation, Procedure Forecast by Country, 1998-2005
Exhibit 2-16: Thoracolumbar Fusions Using Traditional Instrumentation, Procedure Forecast by Country, 1998-2005
Exhibit 2-17: Traditional Spine Instrumentation, Market Forecast, 1998-2005
Exhibit 2-18: Traditional Instrumentation, Market Forecast by Country, 1998-2005
Exhibit 2-19: Traditional Cervical Instrumentation, Market Forecast by Country, 1998-2005
Exhibit 2-20: Traditional Thoracolumbar Instruments, Market Forecast by Country 1998-2005
Exhibit 2-21: Traditional Instrumentation, Supplier Shares, 2000
Exhibit 2-22: Comparison of Materials Used for Interbody Fusion Devices
Exhibit 2-23: Interbody Fusion Device Designs
Exhibit 2-24: Approaches and Techniques Used for Interbody Fusion Devices
Exhibit 2-25: Reasons for Failure of Interbody Fusion Device Procedures
Exhibit 2-26: Selected Interbody Fusion Devices, 2000
Exhibit 2-27: Clinical Results of Osta-Pek Cage in Two Trials
Exhibit 2-28: Spinal Fusions Using IBFDs, Procedure Forecast, 1998-2005
Exhibit 2-29: Cervical Spinal Fusions Using IBFDs by Country, 1998-2005
Exhibit 2-30: Thoracolumbar Spinal Fusions Using IBFDs by Country, 1998-2005
Exhibit 2-31: Cervical IBFDs, Market Forecast by Country, 1998-2005
Exhibit 2-32: Thoracolumbar IBFDs, Market Forecast by Country, 1998-2005
Exhibit 2-33: Interbody Fusion Devices, Supplier Shares, 2000
Exhibit 2-34: Selected Bone Dowels and Allograft Implants, 2000
Exhibit 2-35: Spinal Fusions Using Allografts, Procedure Forecast, 1998-2005
Exhibit 2-36: Allograft Implants Market Forecast by Segment, 1998-2005
Exhibit 2-37: Allograft Implants, Supplier Shares, 2000
Exhibit 2-38: Endoscopic Fusion, Procedure and Market Forecasts, 1998-2005
3.0 MINIMALLY INVASIVE DISCECTOMY
3.1 Microdiscectomy Techniques
3.1.1 Microlumbar Discectomy
3.1.2 Percutaneous Discectomy
3.1.3 Endoscopic Discectomy
3.1.4 Microendoscopic Discectomy
3.2 Indications
3.3 Patient Profile
3.4 Complications
3.5 Procedure Costs
3.6 Products and Technology
3.6.1 Visualization and Access Products
3.6.1.1 Biomet/EBI
3.6.1.2 Blackstone Medical
3.6.1.3 Clarus Medical
3.6.1.4 Endius
3.6.1.5 Sofamor Danek
3.6.1.6 Surgical Dynamics
3.6.1.7 Richard Wolf Medical Instruments
3.6.2 Disc Removal Technologies
3.6.2.1 Chemonucleolysis (Knoll AG)
3.6.2.2 Manual and Powered Cutters
3.6.2.2.1 Endius
3.6.2.2.2 Surgical Dynamics
3.6.2.3 Electrothermal (ArthroCare)
3.6.2.4 Laser-Assisted Discectomy
3.6.2.4.1 Clarus Medical
3.6.2.4.2 Coherent Medical Systems
3.6.2.4.3 Laserscope
3.6.2.4.4 Trimedyne
3.7 Emerging Competitive Techniques
3.8 Procedure Forecasts
3.8.1 Primary Discectomies
3.8.2 Minimally Invasive Discectomies
3.9 Market Analysis
3.10 Supplier Shares
Exhibit 3-1: Intervertebral Disc Illustrations
Exhibit 3-2: Comparison of Minimally Invasive Discectomy Techniques
Exhibit 3-3: Advantages and Disadvantages of MI Discectomy Techniques
Exhibit 3-4: Indications for Minimally Invasive Discectomy
Exhibit 3-5: Most Common Clinical Manifestations of Lumbar Disc Herniation
Exhibit 3-6: Risks Associated with Minimally Invasive Discectomy
Exhibit 3-7: Cost of Laminectomy versus Laparoscopic Lumbar Discectomy
Exhibit 3-8: Product Options for Minimally Invasive Discectomy
Exhibit 3-9: METRx System Outcomes Assessment Data
Exhibit 3-10: Comparison of Disc Removal Techniques
Exhibit 3-11: Discectomies, Procedure Forecast by Type and Country, 1998-2005
Exhibit 3-12: MI Discectomy Procedures by Country, 1998-2005
Exhibit 3-13: MI Discectomy Products, Market Forecast by Country, 1998-2005
Exhibit 3-14: MI Discectomy Products, Supplier Shares, 2000
4.0 BONE GRAFT SUBSTITUTES AND GROWTH FACTORS
4.1 Performance Properties
4.2 Bone Graft Substitutes
4.2.1 Types of Bone Graft Materials
4.2.1.1 Autograft
4.2.1.2 Base Allograft
4.2.1.3 Demineralized Bone Matrix
4.2.1.4 Ceramic and Synthetic Bone Graft Substitutes
4.2.1.5 Xenograft
4.2.2 Applications
4.2.3 Regulatory Issues
4.2.3.1 General EC Directives
4.2.3.2 Allograft Products
4.2.3.2.1 Classification
4.2.3.2.2 Current Practices
4.2.3.2.3 European Guidelines
4.2.3.3 Xenograft Products
4.2.3.4 Bone Graft Substitutes
4.2.3.5 Demineralized Bone Matrix
4.2.4 Products and Suppliers
4.2.4.1 Biomet Merck
4.2.4.2 GenSci Regeneration Sciences
4.2.4.3 Interpore Cross International
4.2.4.4 NeuColl
4.2.4.5 Orquest/Sulzer
4.2.4.6 Orthovita
4.2.4.7 Osteotech
4.2.4.7.1 Grafton DBM
4.2.4.7.2 Lubboc and OsteoPure
4.2.4.8 Regeneration Technologies/Sofamor Danek
4.2.4.9 Tutogen Medical
4.2.4.10 Wright Medical Technology
4.2.4.10.1 OsteoSet
4.2.4.10.2 AlloMatrix
4.2.5 Procedure Forecasts
4.2.6 Market Analysis
4.2.6.1 Base Allograft
4.2.6.2 Xenograft
4.2.6.3 Demineralized Bone Matrix
4.2.6.4 Synthetic Bone Graft Substitutes
4.3 Bone Growth Factors
4.3.1 Background
4.3.2 Product Components
4.3.2.1 Delivery Agents
4.3.2.2 Growth Factor Technologies
4.3.3 Regulatory and Reimbursement Issues
4.3.4 Platelet Derived Growth Factors
4.3.4.1 Interpore Cross International
4.3.4.1.1 AGF Product Description
4.3.4.1.2 Regulatory Status and Product Usage
4.3.4.1.3 Product Settings & Requirements
4.3.4.1.4 Product Features
4.3.4.1.5 Clinical Experience
4.3.4.2 Harvest Technologies
4.3.4.2.1 SmartPReP Product Description
4.3.4.2.2 Regulatory Status and Distribution
4.3.4.2.3 Product Settings & Requirements
4.3.4.2.4 Product Features
4.3.4.2.5 Clinical Experience
4.3.4.2.6 Product Pricing & Reimbursement
4.3.5 Bone Morphogenetic Proteins (BMPs)
4.3.5.1 Genetics Institute
4.3.5.1.1 Product Description
4.3.5.1.2 Advantages and Limitations
4.3.5.1.3 Clinical Experience
4.3.5.1.4 Regulatory Status
4.3.5.1.5 Pricing & Distribution
4.3.5.2 Stryker
4.3.5.2.1 OP-1 Implant
4.3.5.2.2 Product Rights
4.3.5.2.3 Product Features and Limitations
4.3.5.2.4 Clinical Experience
4.3.5.2.5 Regulatory Status and Indications
4.3.5.2.6 Pricing
4.3.5.2.7 Distribution
4.3.5.3 Orquest/Biopharm GmbH
4.3.5.3.1 Development Background
4.3.5.3.2 Product Description
4.3.5.3.3 Regulatory Status and Distribution
4.3.6 Local Gene Therapy for Spinal Fusion
4.3.6.1 Sofamor Danek
4.3.6.2 Selective Genetics
4.3.7 Other Emerging Competitors
4.3.7.1 OrthoLogic
4.3.7.2 Sulzer Biologics
4.3.7.3 Osiris Therapeutics
4.3.8 Procedure and Market Forecast
Exhibit 4-1: Design Criteria for “Ideal” Bone Graft Product
Exhibit 4-2: Types and Features of Bone Graft Materials
Exhibit 4-3: EC Directives Relating to Importation and Use of Animal Tissue
Exhibit 4-4: Base Allograft Products, 2000
Exhibit 4-5: Selected Xenograft Products, 2000
Exhibit 4-6: Selected Synthetic Bone Graft Substitutes, 2000
Exhibit 4-7: Selected Demineralized Bone Matrix Products, 2000
Exhibit 4-8: Bone Graft Substitutes, Procedure Forecast, 1998-2005
Exhibit 4-9: Bone Graft Substitutes, Market Forecast, 1998-2005
Exhibit 4-10: Base Allograft, Market Forecast by Country, 1998-2005
Exhibit 4-11: Xenograft, Market Forecast by Country, 1998-2005
Exhibit 4-12: Demineralized Bone Matrix, Market Forecast by Country, 1998-2005
Exhibit 4-13: Synthetic Graft Substitutes, Market Forecast by Country, 1998-2005
Exhibit 4-14: Selected Bone Growth Factors, 2000
Exhibit 4-15: Advantages and Limitations of BMPs
Exhibit 4-16: Bone Growth Factors, Procedure and Market Forecast, 1998-2005
5.0 EMERGING ALTERNATIVES TO SPINAL FUSION
5.1 Clinical Goals
5.2 IntraDiscal ElectroThermal Therapy
5.2.1 Product
5.2.2 IDET Procedure
5.2.3 Clinical Experience
5.2.4 Indications and Benefits
5.2.5 Regulatory Status
5.2.6 Pricing & Reimbursement
5.2.7 Distribution
5.2.8 Procedure Forecasts
5.2.9 Market Analysis
5.3 Prosthetic Discs
5.3.1 Approaches
5.3.1.1 Total Disc Replacement
5.3.1.1.1 Technology
5.3.1.1.2 Indications
5.3.1.2 Nucleus Replacement
5.3.1.2.1 Technology
5.3.1.2.2 Indications
5.3.2 Regulatory Issues
5.3.3 Prosthetic Disc Products
5.3.3.1 DePuy AcroMed
5.3.3.1.1 Product Description and Clinical Development
5.3.3.1.2 Product Requirements
5.3.3.1.3 Regulatory Status
5.3.3.2 Disc Replacement Technologies
5.3.3.3 Frenchay Hospital
5.3.3.4 Interpore Cross International
5.3.3.5 Waldemar Link
5.3.3.5.1 Product Development
5.3.3.5.2 Product Description
5.3.3.5.3 Implantation
5.3.3.5.4 Indications
5.3.3.5.5 Clinical Experience
5.3.3.5.6 Regulatory Status and Distribution
5.3.3.6 ReGen Biologics
5.3.3.7 Sofamor Danek
5.3.3.8 Spinal Dynamics
5.3.3.9 Spine Solutions
5.3.3.9.1 Product Features
5.3.3.9.2 Implantation
5.3.3.9.3 Clinical Experience
5.3.3.9.4 Regulatory Status and Distribution
5.3.3.9.5 Additional Products
5.3.3.10 Ulrich GmbH
5.3.4 Nucleus Replacement Products
5.3.4.1 Cryolife
5.3.4.2 Disc Dynamics
5.3.4.2.1 Implantation
5.3.4.2.2 Clinical Status
5.3.4.3 Li Medical
5.3.4.4 Raymedica
5.3.4.4.1 Product Description
5.3.4.4.2 Implantation
5.3.4.4.3 Complications
5.3.4.4.4 Indications
5.3.4.4.5 Clinical Experience
5.3.4.4.6 Regulatory Status
5.3.4.4.7 Pricing and Distribution
5.3.4.5 Stryker Howmedica
5.3.4.6 Sulzer Medica
5.3.5 Procedure and Market Forecasts
5.3.5.1 Total Artificial Discs
5.3.5.2 Nucleus Replacement Products
5.4 Disc Regeneration
5.4.1 Primer on Gene Therapy
5.4.1.1 Gene Selection
5.4.1.2 Delivery Vehicles
5.4.1.3 Delivery Approaches
5.4.2 Clinical Goals of Gene Therapy in the Spine
5.4.2.1 Nucleus Pulposus Regeneration
5.4.2.1.1 University of Pittsburgh
5.4.2.1.2 University of Pennsylvania
5.4.2.2 Total Disk Restoration (Rush University)
Exhibit 5-1: Twelve-Month IDET Clinical Results by Levels Treated
Exhibit 5-2: Overview of Intradiscal Electrothermal Therapy
Exhibit 5-3: IntraDiscal Electrothermal Therapy, Procedure Forecast, 1998-2005
Exhibit 5-4: IDET Therapy Products, Market Forecast, 1998-2005
Exhibit 5-5: Total Disc Replacement versus Nucleus Replacement
Exhibit 5-6: Selected Disc Replacement Products and Programs, 2000
Exhibit 5-7: Selected Nucleus Replacement Products and Programs, 2000
Exhibit 5-8: Disc Replacements, Procedure and Market Forecasts, 1998-2005
Exhibit 5-9: Artificial Discs, Procedure & Market Forecasts by Country, 1998-2005
Exhibit 5-10: Nucleus Replacements, Procedure and Market Forecasts by Country, 1998-2005
Exhibit 5-11: Gene Therapy Delivery Options
Exhibit 5-12: Selected Disc Regeneration Programs, 2000
6.0 SPINAL BONE GROWTH STIMULATORS
6.1 Physiology of Fracture Healing
6.2 Technology
6.2.1 Electrical Bone Growth Stimulators
6.2.1.1 Direct Current
6.2.1.2 Capacitive Coupling
6.2.1.3 Pulsed Electromagnetic Field
6.2.1.4 Combined Magnetic Field
6.2.2 Ultrasound Bone Growth Stimulators
6.3 Products
6.3.1 Biolectron
6.3.2 Biomet (EBI)
6.3.3 Orthofix
6.3.4 Orthologic
6.3.5 Emerging Ultrasound Products
6.4 Emerging Applications
6.4.1 Osteoporosis
6.4.1.1 Exogen
6.4.1.2 Orthofix
6.4.2 Angiogenesis (Orthofix)
6.5 Reimbursement
6.6 Patient Forecast
6.7 Market Analysis
6.8 Supplier Shares
Exhibit 6-1: Types of Bone Growth Stimulation Devices
Exhibit 6-2: Current and Emerging Spinal Bone Growth Stimulators, 2000
Exhibit 6-3: Spinal Bone growth Stimulation, Procedure Forecast, 1998-2005
Exhibit 6-4: Spinal Bone Growth Stimulators, Market Forecast, 1998-2005
Exhibit 6-5: Spinal Bone Growth Stimulators, Supplier Shares, 2000
7.0 SPINAL ROBOTICS
7.1 Background
7.2 Technology
7.2.1 Automated Mechanical Assist Devices
7.2.2 Telemanipulators
7.2.3 Autonomous Robots
7.3 Applications in Spine Surgery
7.4 Regulatory Issues
7.5 Products
7.5.1 Accuray Oncology
7.5.1.1 Planning System
7.5.1.2 Image Guided System
7.5.1.3 Approval and Installation Sites
7.5.2 Armstrong Healthcare Limited
7.5.2.1 EndoAssist
7.5.2.2 PathFinder
7.5.3 Brock Rogers Surgical
7.5.4 Computer Motion
7.5.4.1 AESOP
7.5.4.2 ZEUS Robotic Surgical System
7.5.5 Fraunhofer Gesellschaft
7.5.5.1 The RoMed Robot
7.5.5.2 Marketing and Approval
7.5.6 Institut fur Angewandte Informatik
7.5.7 Integrated Surgical Systems
7.5.8 Intuitive Surgical
7.5.8.1 DaVinci Surgical System
7.5.8.2 InSite Visualization System
7.5.8.3 Endo Wrist Technology
7.5.8.4 Advantages
7.5.8.5 Applications and Approvals
7.5.9 jojumarie Intelligente Instrumente GmbH
7.5.9.1 Components
7.5.9.2 Surgical Procedure
7.5.10 Micro Dexterity Systems
7.5.10.1 RAMS Prototype Robot
7.5.10.1.1 Mechanical Subsystem
7.5.10.1.2 Electronic Subsystem
7.5.10.1.3 Servo-Control Subsystem
7.5.10.1.4 Software Subsystem
7.5.10.2 NeuroDex and MicroDex
7.5.11 ortoMaquet
7.5.12 Universal Robot Systems
7.5.13 University of California at Berkley
7.5.13.1 Components
7.5.13.2 Tactile Feedback Device
7.5.13.3 Approval and Marketing
7.5.14 Carl Zeiss
7.6 Market Analysis
Exhibit 7-1: Types of Surgical Robotics
Exhibit 7-2: Current & Emerging Applications for Robotics in Spine Surgery
Exhibit 7-3: Selected Robotic Systems with Potential Application to the Spine, 2000
Exhibit 7-4: CyberKnife System
Exhibit 7-5: EndoAssist Mechanical Assist Device
Exhibit 7-6: Computer Motion ZEUS and AESOP Systems
Exhibit 7-7: ARTEMIS Robotic System
Exhibit 7-8: Intuitive Surgical daVinci System
Exhibit 7-9: MicroDexterity RAMS Device
Exhibit 7-10: Universal Robot Systems' Evolution 1
Exhibit 7-11: Spinal Robotic Systems, Market Forecast, 1998-2005
8.0 MANAGEMENT OF VERTEBRAL FRACTURES AND TUMORS
8.1 Indications
8.1.1 Osteoporotic Compression Fractures
8.1.2 Vertebral Trauma Fractures
8.1.3 Malignant Spinal Tumors
8.1.4 Spinal Hemangiomas
8.2 Clinical Goals of Therapy
8.3 Techniques
8.3.1 Vertebroplasty
8.3.1.1 Technique
8.3.1.2 Setting and Specialties
8.3.1.3 Clinical Experience
8.3.1.4 Product Requirements
8.3.1.5 Contraindications
8.3.1.6 Reimbursement
8.3.1.7 Regulatory Issues
8.3.1.8 Bone Cements Used in Vertebroplasty
8.3.1.8.1 Codman & Shurtleff
8.3.1.8.2 Howmedica Osteonics (Stryker)
8.3.1.8.3 Zimmer
8.3.1.9 Emerging Vertebroplasty Products
8.3.1.9.1 Orthovita
8.3.1.9.2 Interpore Cross International
8.3.1.9.3 Regeneration Technologies
8.3.2 Kyphoplasty
8.3.2.1 Technique
8.3.2.2 Setting and Specialties
8.3.2.3 Product Requirements
8.3.2.4 Patient Profile
8.3.2.5 Advantages and Limitations
8.3.2.6 Clinical Experience
8.3.2.7 Regulatory Status and Distribution
8.3.2.8 Reimbursement
8.3.2.9 Product Launch and Training
8.3.2.10 Emerging Applications for Kyphoplasty Products
8.3.3 Vertebral Body Replacement
8.3.3.1 Technique
8.3.3.2 Indications
8.3.3.3 Contraindications
8.3.3.4 Complications
8.3.3.5 Product Requirements
8.3.3.6 Clinical Experience
8.3.3.7 Vertebral Body Replacement Devices
8.3.3.7.1 Biomet Merck
8.3.3.7.2 DePuy AcroMed
8.3.3.7.3 Industrias Quirugicas de Levante
8.3.3.7.4 Interpore Cross International
8.3.3.7.5 Synthes-Stratec
8.3.3.7.6 Ulrich Medizintechnik
8.4 Procedure Forecasts
8.5 Market Analysis
8.6 Supplier Shares
Exhibit 8-1: Major Indications for Vertebral Intervention
Exhibit 8-2: Techniques for Managing Vertebral Fractures and Tumors
Exhibit 8-3: Relative Contraindications to Vertebroplasty
Exhibit 8-4: Selected Bone Cements, 2000
Exhibit 8-5: Advantages and Limitations of Kyphoplasty
Exhibit 8-6: Indications for Vertebral Body Replacement
Exhibit 8-7: Cancers With Probable Bone Metastases, 1996
Exhibit 8-8: Contraindications for Vertebral Body Replacement
Exhibit 8-9: Potential Complications Associated with Vertebral Body Replacement
Exhibit 8-10: Selected Vertebral Body Replacement Devices, 2000
Exhibit 8-11: Vertebral Fracture/Tumor Management, Procedure Forecast, 1998-2005
Exhibit 8-12: Vertebroplasty, Procedure Forecast by Country, 1998-2005
Exhibit 8-13: Vertebral Fracture Management Products, Market Forecast, 1998-2005
Exhibit 8-14: Bone Cements, Market Forecast, 1998-2005
Exhibit 8-15: Kyphoplasty Products, Market Forecast, 1998-2005
Exhibit 8-16: Vertebral Body Replacement Devices, Market Forecast, 1998-2005
Exhibit 8-17: Vertebral Body Devices, Market Forecast by Country, 1998-2005
Exhibit 8-18: Vertebral Body Replacement Devices, Supplier Shares, 2000
9.0 COUNTRY PROFILES
9.1 Overview of European Healthcare
9.1.1 Healthcare Spending and Reform
9.1.2 Healthcare Facilities and Manpower
9.1.3 Reimbursement
9.1.4 Impact of the European Community
9.1.4.1 EC Directives
9.1.4.2 Pricing
9.2 National Profiles
9.2.1 Germany
9.2.1.1 Health Care Statistical Overview
9.2.1.2 Emerging Legislation
9.2.1.3 Spinal Products Market
9.2.2 France
9.2.2.1 Health Care Statistical Overview
9.2.2.2 Medical Products Regulation
9.2.2.3 Spinal Products Market
9.2.3 Italy
9.2.3.1 Emerging Private Sector
9.2.3.2 Product Issues
9.2.3.3 Spinal Products Market
9.2.4 Spain
9.2.4.1 Structure of health Care Funding and Delivery
9.2.4.2 Overview of Health Statistics
9.2.4.3 Ambulatory Care Reforms
9.2.4.4 Product Issues
9.2.4.5 Spinal Products Market
9.2.5 United Kingdom
9.2.5.1 National Health System
9.2.5.2 Medical Products Regulation
9.2.5.3 Prevalence of Back Pain
9.2.5.4 Health Statistics Overview
9.2.5.5 Spinal Products Market
9.2.6 Benelux Nations
9.2.6.1 Health Care Systems
9.2.6.1.1 Belgium
9.2.6.1.2 Luxembourg
9.2.6.1.3 Netherlands
9.2.6.2 Spinal Products Market
Exhibit 9-1: Health Care Expenditures by Country, 1999
Exhibit 9-2: Practicing Physicians by Country, 1999
Exhibit 9-3: Acute Care Hospital Beds and Utilization, 1999
Exhibit 9-4: Germany, Health Care Profile, 1999
Exhibit 9-5: Spinal Products Market in Germany, 1998-2005
Exhibit 9-6: France, Health Care Profile, 1999
Exhibit 9-7: Spinal Products Market in France, 1998-2005
Exhibit 9-8: Italy, Health Care Profile, 1999
Exhibit 9-9: Spinal Products Market in Italy, 1998-2005
Exhibit 9-10: Spain, Health Care Profile, 1999
Exhibit 9-11: Spinal Products Market in Spain, 1998-2005
Exhibit 9-12: Prevalence of Back Pain in Great Britain, 1998
Exhibit 9-13: United Kingdom, Health Care Profile, 1999
Exhibit 9-14: Spinal Products Market in the United Kingdom, 1998-2005
Exhibit 9-15: Benelux Nations, Health Care Profiles, 1999
Exhibit 9-16: Spinal Products Market in Benelux Nations, 1998-2005
10.0 COMPANY PROFILES
10.1 B. Braun Melsungen AG (Aesculap)
10.2 Biolectron
10.3 Biomet/EBI
10.4 Clarus Medical Systems
10.5 Computer Motion
10.6 Corin Group Limited
10.7 Cremascoli Ortho Group
10.8 Endius Inc
10.9 Implex Corporation
10.10 Integrated Surgical Systems
10.11 Intuitive Surgical
10.12 IsoTis NV
10.13 Johnson & Johnson (DePuy AcroMed, Codman & Shurtleff)
10.14 Kyphon Inc
10.15 Medtronic Sofamor Danek
10.16 ORATEC Interventions Inc.
10.17 Orthofix International
10.18 Orthologic
10.19 Orthovita
10.20 Osteotech
10.21 Raymedica Inc
10.22 Scient'X
10.23 Smith & Nephew plc (Dyonics, Exogen)
10.24 Stryker Corporation (Howmedica Osteonics)
10.25 Sulzer Medica Ltd
10.26 Synthes-Stratec
10.27 Tutogen Medical Inc
10.28 Tyco International Ltd. (Surgical Dynamics)
10.29 Waldemar Link GmbH & Company
10.30 Wright Medical Corporation
Appendix: List of Companies
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