Opportunities in European Spinal Product Markets

Companies Covered

B. Braun Melsungen AG (Aesculap) 

Biomet, Inc. (EBI, IQL)

Biorthex, Inc. 

Centerpulse AG (Spine-Tech)

Corin Group PLC

Endius, Inc. 

Interpore Cross International, Inc. 

IsoTis SA/GenSci Regeneration Sciences, Inc. 

Johnson & Johnson (DePuy AcroMed) 

Kyphon, Inc.

Link Spine Group, Inc.

Medtronic, Inc. (Sofamor Danek)

Orquest, Inc.

Orthofix International NV

Orthovita, Inc. 

Osteotech, Inc. 

Raymedica, Inc. 

Scient'x SA 

Smith & Nephew, plc

Spinal Concepts, Inc. 

Spine Network (Eurosurgical) 

Spine Solutions, Inc. 

Stryker Corporation (Howmedica Osteonics, Surgical Dynamics) 

Surgicraft Limited

Synthes-Stratec, Inc. 

Wright Medical Group, Inc.

Table of Contents

EXECUTIVE SUMMARY 

Procedure Trends 

Fusion Instrumentation 

Prosthetic Discs

Bone Graft Substitutes and Growth Factors 

Vertebral Fracture Management 

Other Spinal Technologies

Suppliers 

Country Profiles 

Summary Exhibit 1: European Spinal Products Market by Major Product Category, 2001-2008

Summary Exhibit 2: Major Spine Procedures, Forecast by Type, 2001-2008

Summary Exhibit 3: Fusion Instrumentation, Market Forecast by Major Type, 2001-2008 

Summary Exhibit 4: Prosthetic Discs, Patient and Market Forecasts by Type, 2001-2008 

Summary Exhibit 5: Bone Graft Substitutes, Market Forecast by Type, 2001-2008 

Summary Exhibit 6: Vertebral Fracture Management, Procedure and Market Forecasts, 2001-2008 

Summary Exhibit 7: Other Spinal Technologies, Procedure and Market Forecasts, 2001-2008 

Summary Exhibit 8: Estimated Supplier Shares, 2002 

Summary Exhibit 9: European Spine Market, Forecasts by Country, 2001-2008

 

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 

1.2.1.2 Herniated Disc 

1.2.1.3 Spinal Stenosis

1.2.1.4 Spondylosis 

1.2.1.5 Spondylolisthesis 

1.2.1.6 Osteoporosis

1.2.1.7 Osteoarthritis

1.2.1.8 Rheumatoid Arthritis 

1.2.2 Spinal Trauma

1.2.2.1 Structural Spinal Trauma 

1.2.2.2 Spinal Cord Trauma

1.2.3 Deformity Disorders 

1.2.3.1 Scoliosis 

1.2.3.2 Kyphosis 

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 Probable Bone Metastases, Deaths, 1996 and 1998

 

2.0 TREND IN EUROPEAN SPINAL FUSIONS

2.1 Clinical Goals and Outcomes

2.1.1 Failure of Fusion 

2.1.2 Failure of Pain Relief 

2.1.3 Long-Term Outcomes

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 

2.3 Specialists Performing Spine Surgery 

2.4 Spinal Fusions by Segment and Instrumentation

2.4.1 Cervical Spine

2.4.2 Thoracolumbar Spine

2.4.2.1 Approaches 

2.4.2.2 Instrumentation Preferences

2.4.2.3 Procedure Forecast

 

Exhibit 2-1: Methods of Categorizing Spinal Fusion Procedures

Exhibit 2-2: Major Surgical Approaches for Spinal Fusion

Exhibit 2-3: Spinal Fusions by Segment, Procedure Forecast, 2001-2008

Exhibit 2-4: Spinal Fusions by Country, Procedure Forecast, 2001-2008

Exhibit 2-5: Fusion Procedures by Surgical Approach, 2002 & 2008

Exhibit 2-6: Instrumented Fusions by Segment, 2001-2008

Exhibit 2-7: Instrumented Cervical Fusions by Modality, Procedure Forecast, 2001-2008 

Exhibit 2-8: Total and Instrumented Cervical Fusions by Country, 2001-2008

Exhibit 2-9: Instrumented Thoracolumbar Fusions by Modality, Procedure Forecast, 2001-2008 

Exhibit 2-10: Total and Instrumented Thoracolumbar Fusions by Country, 2001-2008

 

3.0 FUSION INSTRUMENTATION 

3.1 Traditional Instrumentation Systems 

3.1.1 Configurations

3.1.1.1 Hook/Screw and Rod Systems

3.1.1.2 Plate Systems 

3.1.1.3. Wires and Clamps 

3.1.2 Products and Suppliers by Segment

3.1.2.1 Thoracolumbar Instrumentation

3.1.2.2 Cervical Instrumentation

3.1.3 Procedure Forecast

3.1.4 Market Analysis 

3.1.4.1 Cervical Instrumentation Systems 

3.1.4.2 Thoracolumbar Instrumentation Systems 

3.1.4.3 Supplier Shares 

3.2 Minimally Invasive Spine Surgery 

3.2.1 Laparoscopic Anterior Spinal Fusion 

3.2.1.1 Procedure 

3.2.1.2 Advantages and Limitations 

3.2.1.3 Products

3.2.1.4 Clinical Experience

3.2.2 Percutaneous Spinal Fusion 

3.2.2.1 Procedure 

3.2.2.2 Advantages and Limitations 

3.2.2.3 Products

3.2.2.3.1 GM Reis

3.2.2.3.2 Medtronic Sofamor Danek

3.2.2.3.3 NuVasive

3.2.2.3.4 Spinal Concepts 

3.2.2.3.5 Synthes-Stratec 

3.2.3 Port-Access Spinal Fusion 

3.2.3.1 Procedure 

3.2.3.2 Advantages and Limitations 

3.2.3.3 Products

3.2.3.4 Clinical Experience

3.2.4 Procedure Forecast

3.2.5 Market Analysis 

3.3 Bioabsorbable Spinal Implants 

3.3.1 Clinical Rationale

3.3.2 Clinical Applications and Products

3.3.3 Market Assessment 

 

Exhibit 3-1: Traditional Instrumentation Product Configurations 

Exhibit 3-2: Selected Thoracolumbar Spine Systems, 2003

Exhibit 3-3: Selected Cervical Spine Systems, 2003 

Exhibit 3-4: Spinal Fusions Using Traditional Instrumentation, Procedure Forecast, 2001-2008 

Exhibit 3-5: Cervical Fusions Using Traditional Instrumentation, Procedure Forecast by Country, 2001-2008 

Exhibit 3-6: Thoracolumbar Fusions Using Traditional Instrumentation, Procedure Forecast by Country, 2001-2008

Exhibit 3-7: Traditional Spinal Instrumentation, Market Forecast, 2001-2008

Exhibit 3-8: Traditional Instrumentation, Market Forecast by Country, 2001-2008

Exhibit 3-9: Traditional Cervical Instrumentation, Market Forecast by Country, 2001-2008 

Exhibit 3-10: Traditional Thoracolumbar Instrumentation, Market Forecast by Country, 2001-2008 

Exhibit 3-11: Traditional Spinal Instrumentation, Supplier Shares, 2002 

Exhibit 3-12: Minimally Invasive Approaches for Spinal Fusion Surgery

Exhibit 3-13: Selected Percutaneous Implantation Systems and Instrumentation, 2003

Exhibit 3-14: Selected Percutaneous Fusion Technologies 

Exhibit 3-15: Selected Port Access Spinal Fusion Products, 2003

Exhibit 3-16: Images of Selected Port-Access Spinal Fusion Products, 2003

Exhibit 3-17: Minimally Invasive Spinal Fusion, Procedure and Market Forecast, 2001-2008 

Exhibit 3-18: Design Criteria for Medical Biodegradable Polymers

Exhibit 3-19: Emerging Spinal Applications for Bioabsorbable Implants 

 

4.0 INTERBODY FUSION DEVICES 

4.1 Performance Criteria and Goals

4.2 Materials 

4.2.1 Metal 

4.2.2 Carbon Fiber 

4.2.3 PEEK

4.2.4 Bioabsorbable Polymers 

4.3 Cage Designs 

4.3.1 Cylindrical Cages

4.3.2 Rectangular Cages 

4.4 Implantation Technique 

4.4.1 Anterior Lumbar Interbody Fusion

4.4.2 Posterior Lumbar Interbody Fusion 

4.4.3 Transforaminal Lumbar Interbody Fusion

4.5 Failure of Interbody Fusion Devices

4.6 Products and Suppliers

4.7 Allograft Implants

4.7.1 Benefits and Limitations 

4.7.2 Materials Supply 

4.7.3 Clinical Experience

4.7.4 Implantation 

4.7.5 Products and Suppliers

4.8 Market Analysis 

4.8.1 Cages

4.8.2 Structural Allografts

 

Exhibit 4-1: Comparison of Materials Used for Interbody Fusion Devices 

Exhibit 4-2: Interbody Fusion Device Designs

Exhibit 4-3: Approaches and Techniques Used for Lumbar Interbody Fusion Devices

Exhibit 4-4: Reasons for Failure of Interbody Fusion Device Procedures 

Exhibit 4-5: Selected Interbody Fusion Devices, 2003

Exhibit 4-6: Selected Structural Allograft Implants, Products and Suppliers, 2003

Exhibit 4-7: Spinal Fusions Using Cages, Procedure Forecast, 2001-2008 

Exhibit 4-8: Cervical Cage Procedures by Country, 2001-2008

Exhibit 4-9: Thoracolumbar Cage Procedures by Country, 2001-2008 

Exhibit 4-10: Cervical Cages, Market Forecast by Country, 2001-2008

Exhibit 4-11: Thoracolumbar Cages, Market Forecast by Country, 2001-2008

Exhibit 4-12: Interbody Fusion Cages, Supplier Shares, 2002 

Exhibit 4-13: Structural Allografts, Procedure and Market Forecast, 2001-2008 

Exhibit 4-14: Structural Allografts, Estimated Supplier Shares, 2002 

 

5.0 BONE GRAFT SUBSTITUTES AND GROWTH FACTORS 

5.1 Performance Properties

5.2 Bone Graft Substitutes 

5.2.1 Types of Bone Graft Materials 

5.2.1.1 Autograft 

5.2.1.2 Base Allograft 

5.2.1.3 Demineralized Bone Matrix

5.2.1.4 Ceramic and Synthetic Bone Graft Substitutes

5.2.1.5 Xenograft 

5.2.2 Applications 

5.2.3 Regulatory Issues 

5.2.3.1 General EC Directives 

5.2.3.2 Allograft Products

5.2.3.3 Xenograft Products 

5.2.3.4 Bone Graft Substitutes 

5.2.3.5 Demineralized Bone Matrix

5.2.4 Products and Suppliers

5.2.5 Procedure Forecasts 

5.2.6 Market Analysis 

5.2.6.1 Allograft

5.2.6.2 Demineralized Bone Matrix

5.2.6.3 Synthetic Substitutes

5.2.6.4 Xenograft 

5.3 Bone Growth Factors 

5.3.1 Background 

5.3.2 Product Components

5.3.3 Autologous-Derived Growth Factors

5.3.4 Bone Morphogenetic Proteins (BMPs)

5.3.4.1 Medtronic Sofamor Danek/Genetics Institute 

5.3.4.1.1 Advantages and Limitations 

5.3.4.1.2 Clinical Experience

5.3.4.2 Stryker

5.3.4.2.1 Advantages and Limitations 

5.3.4.2.2 Clinical Experience

5.3.4.2.3 Regulatory Status 

5.3.4.2.4 Product Rights

5.3.4.2.5 Distribution 

5.3.4.3 Orquest/DePuy/Biopharm GmbH

5.3.5 Local Gene Therapy for Spinal Fusion

5.3.5.1 Medtronic Sofamor Danek

5.3.5.2 Millenium Biologics 

5.3.5.3 OrthoLogic

5.3.5.4 Osiris Therapeutics 

5.3.5.5 Selective Genetics

5.3.6 Procedure and Market Forecast 

 

Exhibit 5-1: Design Criteria for "Ideal" Bone Graft Product 

Exhibit 5-2: Types and Features of Bone Graft Materials 

Exhibit 5-3: European Community Directives Relating to Importation and Use of Animal Tissue 

Exhibit 5-4: Selected Base Allograft Products, 2003

Exhibit 5-5: Selected Xenograft Products, 2003

Exhibit 5-6: Selected Synthetic Bone Graft Substitutes, 2003 

Exhibit 5-7: Selected Demineralized Bone Matrix Products, 2003 

Exhibit 5-8: Bone Graft Substitutes, Procedure Forecast, 2001-2008 

Exhibit 5-9: Traditional Bone Graft Substitutes, Market Forecast, 2001-2008

Exhibit 5-10: Traditional Bone Graft Substitutes, Market Forecast by Country, 2001-2008 

Exhibit 5-11: Approaches for Incorporating Growth Factors into Bone Graft Products

Exhibit 5-12: Selected Bone Growth Factor Programs, 2003

Exhibit 5-13: Comparison of Selected Platelet-Derived Growth Factor Technologies

Exhibit 5-14: Advantages and Limitations of BMPs 

Exhibit 5-15: Bone Growth Factors, Procedure and Market Forecast, 2001-2008

Exhibit 5-16: Bone Morphogenetic Proteins, Market Forecast by Country, 2001-2008

 

6.0 PROSTHETIC DISCS 

6.1 Approaches 

6.1.1 Total Disc Replacement

6.1.1.1 Technology 

6.1.1.2 Indications

6.1.2 Nucleus Replacement

6.1.2.1 Technology 

6.1.2.2 Indications

6.2 Implantation Techniques

6.2.1 Total Disc Implantation 

6.2.2 Nucleus Implantation 

6.3 Total Prosthetic Disc Products

6.3.1 LDR Médical 

6.3.2 Link Spine Group (DePuy AcroMed)

6.3.2.1 Background 

6.3.2.2 Product Description 

6.3.2.3 Implantation 

6.3.2.4 Indications

6.3.2.5 Clinical Experience

6.3.2.6 Distribution 

6.3.2.7 Additional Products 

6.3.3 Medtronic Sofamor Danek

6.3.3.1 Maverick 

6.3.3.2 Prestige

6.3.3.3 Bryan (Spinal Dynamics)

6.3.3.3.1 Product Description 

6.3.3.3.2 Implantation 

6.3.3.3.3 Clinical Experience

6.3.3.3.4 Regulatory Status 

6.3.4 Scient'x 

6.3.5 SpineCore

6.3.6 Spine Solutions (Synthes) 

6.3.6.1 Product Description 

6.3.6.2 Implantation 

6.3.6.3 Clinical Experience

6.3.6.4 Regulatory Status 

6.4 Nucleus Replacement Products

6.4.1 Centerpulse Spine-Tech 

6.4.1.1 Product Description 

6.4.1.2 Implantation 

6.4.1.3 Indications and Benefits

6.4.1.4 Clinical Experience

6.4.1.5 Regulatory Status 

6.4.2 Raymedica

6.4.2.1 Product Description 

6.4.2.2 Implantation 

6.4.2.3 Complications 

6.4.2.4 Indications and Contraindications

6.4.2.5 Clinical Experience

6.4.2.6 Regulatory Status 

6.4.2.7 Distribution 

6.5 Disc Regeneration

6.6 Market Analysis 

6.6.1 Procedure Forecasts 

6.6.2 Market Forecasts

6.6.3 Competitive Analysis

 

Exhibit 6-1: Total Disc Replacement versus Nucleus Replacement

Exhibit 6-2: Overview of Indication Criteria for Total Disc Replacement

Exhibit 6-3: Selected Total Disc Replacement Products, 2003 

Exhibit 6-4: LDR Médical's Mobidisc 

Exhibit 6-5: Evolution of the LINK SB Charité Intervertebral Dynamic Disc Spacer

Exhibit 6-6: Sofamor Danek's Disc Replacement Technologies

Exhibit 6-7: SpineCore's FlexiCore Intervertebral Disc

Exhibit 6-8: Spine Solutions' ProDisc 

Exhibit 6-9: Selected Nucleus Replacement Products and Programs, 2003

Exhibit 6-10: Centerpulse Spine-Tech's Newcleus Implant

Exhibit 6-11: Raymedica's PDN Prosthetic Disc Nucleus 

Exhibit 6-12: Indications & Contraindications for the Prosthetic Disc Nucleus 

Exhibit 6-13: Selected Disc Regeneration Programs, 2003 

Exhibit 6-14: Market Drivers and Concerns of Prosthetic Disc Products 

Exhibit 6-15: Recent Acquisitions of Prosthetic Disc Companies

Exhibit 6-16: Prosthetic Disc Products, Procedure Forecast, 2001-2008 

Exhibit 6-17: Prosthetic Disc Products, Market Forecast, 2001-2008

Exhibit 6-18: Total Disc Replacements, Procedure and Market Forecast by Country, 2001-2008 

Exhibit 6-19: European Market for Total Disc Replacements, Supplier Shares by Segment, 2002

 

7.0 MANAGEMENT OF VERTEBRAL FRACTURES AND TUMORS 

7.1 Indications

7.1.1 Osteoporotic Compression Fractures

7.1.2 Vertebral Trauma Fractures 

7.1.3 Malignant Spinal Tumors 

7.1.4 Spinal Hemangiomas 

7.2 Clinical Goals of Therapy

7.3 Techniques 

7.3.1 Vertebroplasty

7.3.1.1 Technique

7.3.1.2 Setting and Specialties 

7.3.1.3 Clinical Experience

7.3.1.4 Contraindications 

7.3.1.5 Reimbursement 

7.3.1.6 Regulatory Issues 

7.3.1.7 Products

7.3.1.7.1 Bone Cements 

7.3.1.7.2 Delivery Systems 

7.3.2 Kyphoplasty 

7.3.2.1 Technique

7.3.2.2 Setting and Specialties 

7.3.2.3 Applications 

7.3.2.4 Advantages and Limitations 

7.3.2.5 Clinical Experience

7.3.2.6 Product Requirements

7.3.2.6.1 Disc-O-Tech Medical Technologies 

7.3.2.6.2 Kyphon

7.3.2.7 Reimbursement 

7.3.3 Vertebral Body Replacement

7.3.3.1 Technique

7.3.3.2 Indications

7.3.3.3 Contraindications 

7.3.3.4 Complications 

7.3.3.5 Product Requirements

7.3.3.6 Clinical Experience

7.3.3.7 Vertebral Body Replacement Devices 

7.4 Procedure Forecasts 

7.5 Market Analysis 

7.6 Supplier Shares 

 

Exhibit 7-1: Major Indications for Vertebral Intervention

Exhibit 7-2: Techniques for Managing Vertebral Fractures and Tumors 

Exhibit 7-3: Relative Contraindications to Vertebroplasty

Exhibit 7-4: Performance Requirements for Vertebroplasty Bone Cement

Exhibit 7-5: Selected Vertebroplasty Bone Cements, 2003

Exhibit 7-6: Current and Emerging Vertebroplasty Cement Delivery Systems, 2003 

Exhibit 7-7: Advantages and Limitations of Kyphoplasty

Exhibit 7-8: Selected Clinical Experience with Kyphoplasty

Exhibit 7-9: Indications for Vertebral Body Replacement 

Exhibit 7-10: Cancers With Probable Bone Metastases, Deaths, 1996 and 1998

Exhibit 7-11: Contraindications for Vertebral Body Replacement

Exhibit 7-12: Potential Complications Associated with Vertebral Body Replacement

Exhibit 7-13: Selected Vertebral Body Replacement Devices, 2003 

Exhibit 7-14: Images of Selected Vertebral Body Replacement Devices, 2003

Exhibit 7-15: Vertebral Fracture and Tumor Management, Procedure Forecast, 2001-2008 

Exhibit 7-16: Vertebroplasty, Procedure Forecast by Country, 2001-2008

Exhibit 7-17: Kyphoplasty, Procedure Forecast by Country, 2001-2008

Exhibit 7-18: Vertebral Body Replacements, Procedure Forecast by Country, 2001-2008 

Exhibit 7-19: Vertebral Fracture Management Products, Market Forecast, 2001-2008

Exhibit 7-20: Bone Cements, Market Forecast, 2001-2008

Exhibit 7-21: Kyphoplasty Disposables, Market Forecast by Country, 2001-2008 

Exhibit 7-22: Vertebral Body Replacement Devices, Market Forecast by Country,2001-2008 

Exhibit 7-23: Vertebral Body Replacement Devices, Supplier Shares, 2002

 

8.0 OTHER SPINAL TECHNOLOGIES

8.1 Surgical Technologies

8.1.1 Flexible Stabilization 

8.1.1.1 Products

8.1.1.1.1 Centerpulse Spine-Tech 

8.1.1.1.2 Mekanika

8.1.1.1.3 St. Francis Medical Technologies

8.1.1.1.4 Spine Next/Clinique St. Martin 

8.1.1.1.5 Surgicraft (Graf Ligamentoplasty)

8.1.1.2 Procedure Trend

8.1.1.3 Market Analysis 

8.1.2 Minimally Invasive Discectomy

8.1.2.1 Microdiscectomy Techniques 

8.1.2.2 Indications

8.1.2.3 Site of Herniation

8.1.2.4 Risks

8.1.2.5 Technologies 

8.1.2.5.1 Chemonucleolysis 

8.1.2.5.2 Manual and Automated Removal 

8.1.2.5.3 Laser-Assisted Discectomy

8.1.2.5.4 Electrothermal

8.1.2.5.5 High Intensity Focused Ultrasound 

8.1.2.6 Products

8.1.2.7 Procedure Trend

8.1.2.8 Market Analysis 

8.1.3 Emerging Surgical Approaches 

8.1.3.1 Annulus Repair 

8.1.3.2 Facet Joint Arthroplasty

8.1.3.3 Extra-Ligamentous Repair 

8.2 Interventional Technologies

8.2.1 Intradiscal Heating (Thermal Therapy) 

8.2.1.1 IntraDiscal ElectroThermal Therapy (Smith & Nephew)

8.2.1.1.1 Product 

8.2.1.1.2 IDET Procedure 

8.2.1.1.3 Clinical Experience

8.2.1.1.4 Indications and Benefits

8.2.1.1.5 Regulatory Status 

8.2.1.1.6 Additional Products 

8.2.1.2 Radiofrequency Annuloplasty (Radionics)

8.2.1.2.1 Product 

8.2.1.2.2 Procedure 

8.2.1.2.3 Clinical Experience

8.2.1.2.4 Indications and Benefits

8.2.1.3 Procedure and Market Forecasts

8.2.2 Ozone Therapy

8.2.3 Percutaneous Neuromodulation Therapy

8.2.3.1 Product 

8.2.3.2 PNT Procedure

8.2.3.3 Clinical Experience

8.2.3.4 Indications and Benefits

8.2.3.5 Regulatory Status 

8.2.4 Intradiscal Hypothermia Therapy 

8.2.4.1 Product 

8.2.4.2 Procedure 

8.2.4.3 Indications and Benefits

8.2.4.4 Clincial Status 

8.3 Spinal Bone Growth Stimulators 

8.3.1 Product Technology

8.3.1.1 Electrical Bone Growth Stimulators 

8.3.1.1.1 Direct Current 

8.3.1.1.2 Capacitive Coupling

8.3.1.1.3 Pulsed Electromagnetic Field 

8.3.1.1.4 Combined Magnetic Field

8.3.1.2 Ultrasound Bone Growth Stimulators

8.3.2 Spinal Applications

8.3.3 Impact of Graft Substitutes and Growth Factors 

8.3.4 Products

8.3.5 Product Trends 

8.3.6 Clinical Experience

8.3.7 Patient Forecast

 

Exhibit 8-1: Selected Flexible Stabilization Technologies, 2003 

Exhibit 8-2: Centerpulse Spine-Tech's DYNESYS System

Exhibit 8-3: Mekanika Modulus 60C System

Exhibit 8-4: The X STOP Interspinous Process Distraction System 

Exhibit 8-5: The Wallis System 

Exhibit 8-6: The Graf System 

Exhibit 8-7: Indications & Contraindications for Graf Ligamentoplasty 

Exhibit 8-8: Flexible Stabilization, Procedure and Market Forecast, 2001-2008

Exhibit 8-9: Flexible Stabilization Systems, Supplier Shares, 2002

Exhibit 8-10: Intervertebral Discs

Exhibit 8-11: Comparison of Minimally Invasive Discectomy Techniques

Exhibit 8-12: Advantages and Limitations of Min. Invasive Discectomy Techniques 

Exhibit 8-13: Indications for Minimally Invasive Discectomy

Exhibit 8-14: Risks Associated with Minimally Invasive Discectomy 

Exhibit 8-15: Comparison of Current and Emerging Disc Removal Techniques

Exhibit 8-16: Selected Minimally Invasive Discectomy Technologies, 2003

Exhibit 8-17: Images of Selected Minimally Invasive Discectomy Technologies, 2003 

Exhibit 8-18: Minimally Invasive Discectomy, Procedure and Market Forecast, 2001-2008 

Exhibit 8-19: Overview of Emerging Surgical Approaches to the Spine 

Exhibit 8-20: Selected Early Stage Annulus Repair Technologies

Exhibit 8-21: Selected Early Stage Facet Joint Replacement Programs, 2003

Exhibit 8-22: Emerging Approaches to Interventional Spine Care 

Exhibit 8-23: Smith & Nephew's IDET Technology 

Exhibit 8-24: IDET: Long-Term Clinical Improvements 

Exhibit 8-25: Randomized, Double-Blinded, Placebo Controlled IDET Trial Results 

Exhibit 8-26: Radionics' discTRODE Technology for RF Annuloplasty 

Exhibit 8-27: Intradiscal Heating, Procedure and Market Forecast, 2001-2008

Exhibit 8-28: The Vertis PNT System 

Exhibit 8-29: Types of Bone Growth Stimulation Devices 

Exhibit 8-30: Selected Spinal Bone Growth Stimulators Marketed in Europe, 2003

Exhibit 8-31: Selected Spinal Bone Growth Stimulators, 2003

Exhibit 8-32: Spinal Bone Growth Stimulation, Patient and Market Forecast, 2001-2008 

Exhibit 8-33: Spinal Bone Growth Stimulators, Supplier Shares, 2002

 

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 

Exhibit 9-2: Practicing Physicians by Country 

Exhibit 9-3: Acute Care Hospital Beds and Utilization 

Exhibit 9-4: Germany, Health Care Profile

Exhibit 9-5: Spinal Products Market in Germany, 2001-2008 

Exhibit 9-6: France, Health Care Profile

Exhibit 9-7: Spinal Products Market in France, 2001-2008 

Exhibit 9-8: Italy, Health Care Profile 

Exhibit 9-9: Spinal Products Market in Italy, 2001-2008 

Exhibit 9-10: Spain, Health Care Profile 

Exhibit 9-11: Spinal Products Market in Spain, 2001-2008 

Exhibit 9-12: United Kingdom, Health Care Profile 

Exhibit 9-13: Spinal Products Market in the United Kingdom, 2001-2008 

Exhibit 9-14: Benelux Nations, Health Care Profiles 

Exhibit 9-15: Spinal Products Market in Benelux Nations, 2001-2008

 

10.0 COMPANY PROFILES

10.1 B. Braun Melsungen AG (Aesculap) 

10.2 Biomet, Inc. (EBI, IQL)

10.3 Biorthex, Inc. 

10.4 Centerpulse AG (Spine-Tech)

10.5 Corin Group PLC

10.6 Endius, Inc. 

10.7 Interpore Cross International, Inc. 

10.8 IsoTis SA/GenSci Regeneration Sciences, Inc. 

10.9 Johnson & Johnson (DePuy AcroMed) 

10.10 Kyphon, Inc.

10.11 Link Spine Group, Inc.

10.12 Medtronic, Inc. (Sofamor Danek)

10.13 Orquest, Inc.

10.14 Orthofix International NV

10.15 Orthovita, Inc. 

10.16 Osteotech, Inc. 

10.17 Raymedica, Inc. 

10.18 Scient'x SA 

10.19 Smith & Nephew, plc

10.20 Spinal Concepts, Inc. 

10.21 Spine Network (Eurosurgical) 

10.22 Spine Solutions, Inc. 

10.23 Stryker Corporation (Howmedica Osteonics, Surgical Dynamics) 

10.24 Surgicraft Limited

10.25 Synthes-Stratec, Inc. 

10.26 Wright Medical Group, Inc.

 

APPENDIX: COMPANY LIST