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Opportunities in European Spinal Product Markets

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

Our Clients