Opportunities in U.S. Spinal Product Markets

Companies Covered

B. Braun Melsungen AG (Aesculap) 

Biolectron

Biomet/EBI

Clarus Medical Systems 

Coherent 

Computer Motion 

Encore Medical Corporation

Endius

GenSci Regeneration Sciences 

Implex Corporation 

Integrated Surgical Systems

Interpore Cross International 

Intuitive Surgical 

Johnson & Johnson (DePuy AcroMed, Codman & Shurtleff)) 

Kyphon

Laserscope

Medtronic Sofamor Danek 

NeuColl 

ORATEC Interventions 

Orquest 

Orthofix International 

OrthoLogic 

Orthovita 

Osteotech

Raymedica 

Regeneration Technologies 

Smith & Nephew plc (Dyonics, Exogen)

Stellar Medical 

Stryker Corporation (Howmedica Osteonics) 

Sulzer Medica Ltd. (Spine-Tech)

Synthes-Stratec

Trimedyne 

Tyco International Ltd. (Surgical Dynamics) 

Waldemar Link GmbH & Company

Wright Medical Corporation

Table of Contents

EXECUTIVE SUMMARY

Spinal Stabilization and Fusion 

Minimally Invasive Diskectomy

Bone Graft Substitutes and Bone Growth Factors 

Fusion Alternatives 

Bone Growth Stimulators

Spinal Robotics 

Vertebral Fracture Management

Companies

 

Summary Exhibit 1: Total Spinal Products, Market Forecast, 1998-2005 

Summary Exhibit 2: Spinal Stabilization & Fusion, Market Forecast, 1998-2005

Summary Exhibit 3: MI Diskectomy, Market Forecast, 1998-2005

Summary Exhibit 4: Bone Graft Substitutes, Market Forecast, 1998-2005

Summary Exhibit 5: Bone Growth Factors, Market Forecast, 1998-2005

Summary Exhibit 6: Fusion Alternatives, Market Forecast, 1998-2005 

Summary Exhibit 7: Bone Growth Stimulators, Market Forecast, 1998-2005

Summary Exhibit 8: Spinal Robotics, Market Forecast, 1998-2005 

Summary Exhibit 9: Vertebral Fractures Mgt, Product Markets, 1998-2005

Summary Exhibit 10: Total Spine Products, Supplier Shares, 2000 

 

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 Disks

1.1.4 Spinal Cord

1.2 Spinal Conditions 

1.2.1 Degenerative Disorders

1.2.1.1 Degenerative Disk 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 Disk 

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 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 

1.2.1.5.2 Diagnosis

1.2.1.5.3 Treatment

1.2.1.6 Osteoporosis

1.2.1.6.1 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 Disk 

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 

 

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 

2.2.5 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 

2.4.2.3.1 Thoracic Fusions 

2.4.2.3.2 Lumbar Fusions 

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 by Regulatory Category

2.5.2.1 Spinal Intervertebral Body Fixation Orthosis 

2.5.2.2 Spinal interlaminal Fixation Orthosis

2.5.2.3 Spondylolisthesis Spinal Fixation Device System

2.5.2.4 Pedicle Screw Spinal System 

2.5.2.5 Facet Screw Device System 

2.5.2.6 Vertebral Body Replacement Device 

2.5.3 Products and Suppliers by Segment 

2.5.3.1 Thoracolumbar Instrumentation 

2.5.3.1.1 Depuy AcroMed

2.5.3.1.2 EBI/Biomet

2.5.3.1.3 Interpore Cross International 

2.5.3.1.4 Sofamor Danek

2.5.3.1.5 Sulzer Spine-Tech

2.5.3.1.6 Stryker Howmedica 

2.5.3.1.7 Surgical Dynamics

2.5.3.1.8 Synthes-Stratec 

2.5.3.2 Cervical Instrumentation 

2.5.3.2.1 Aesculap 

2.5.3.2.2 Depuy AcroMed

2.5.3.2.3 EBI/Biomet

2.5.3.2.4 Sofamor Danek

2.5.3.2.5 Synthes-Stratec 

2.5.4 Product Trends

2.5.4.1 Dynamic Neutralization of the Spine 

2.5.4.1.1 Sulzer Orthopedics 

2.5.4.1.2 Mekanika

2.5.4.2 Bioabsorbable Spinal Implants

2.5.4.3 Other Developments

2.5.5 Regulatory Issues

2.5.6 Reimbursement 

2.5.7 Market Analysis

2.5.7.1 Cervical Instrumentation Systems 

2.5.7.2 Thoracic Instrumentation Systems 

2.5.7.3 Lumbar Instrumentation

2.5.7.4 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 Corin Spinal Systems 

2.6.6.4 DePuy AcroMed

2.6.6.4.1 Lumbar I/F

2.6.6.4.2 Surgical Titanium Mesh 

2.6.6.5 Encore Medical 

2.6.6.6 Implex 

2.6.6.7 Medtronic/Sofamor Danek 

2.6.6.7.1 Inter Fix 

2.6.6.7.2 Inter Fix RP 

2.6.6.7.3 Inter Fix C 

2.6.6.7.4 Lumbar Tapered Interbody Fusion Device

2.6.6.7.5 Incline Series 

2.6.6.8 Spinal Concepts

2.6.6.9 Spinal Innovations

2.6.6.10 The Spineology Group 

2.6.6.11 Stellar Medical 

2.6.6.12 Sulzer Spine-Tech 

2.6.6.12.1 BAK Interbody Fusion System

2.6.6.12.2 BAK Proximity

2.6.6.12.3 BAK/C Cervical Cage 

2.6.6.13 Surgical Dynamics 

2.6.6.14 Surgicraft Limited (Hartshill Horseshoe) 

2.6.6.15 Synthes-Stratec

2.6.6.15.1 Titanium Interbody Spacer 

2.6.6.15.2 SynCage

2.6.6.15.3 Contact Fusion Cage

2.6.6.15.4 SynCage C

2.6.7 Procedure Forecast

2.6.8 Market Analysis

2.6.8.1 Cervical Interbody Fusion Devices 

2.6.8.2 Thoracic Interbody Fusion Devices

2.6.8.3 Lumbar Interbody Fusion Devices 

2.6.8.4 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 Regulation

2.7.5 Implantation

2.7.6 Products 

2.7.6.1 Cortek 

2.7.6.2 DePuy AcroMed

2.7.6.3 Orthovita 

2.7.6.4 Osteotech 

2.7.6.5 Sofamor Danek/Regeneration Technologies 

2.7.6.6 Sulzer Medica/Tutogen Medical 

2.7.6.7 Synthes-Stratec

2.7.7 Procedures 

2.7.8 Market Analysis

2.7.9 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: Fusion Procedures by Surgical Approach, 1999 & 2005 

Exhibit 2-5: Instrumented Fusions by Segment, 1998-2005 

Exhibit 2-6: Cervical Fusions, Procedure Forecast by Instrumentation, 1998-2005 

Exhibit 2-7: Cervical Fusions by Level Fused, 1999, 2001 and 2005

Exhibit 2-8: Thoracic Fusions, Procedure Forecast by Instrumentation, 1998-2005

Exhibit 2-9: Thoracic Fusions by Level Fused, 1999, 2001 and 2005 

Exhibit 2-10: Lumbar Fusions, Procedure Forecast by Instrumentation, 1998-2005 

Exhibit 2-11: Lumbar Fusions by Level Fused, 1999, 2001 and 2005

Exhibit 2-12: Traditional Instrumentation Product Configurations 

Exhibit 2-13: Spinal Instrumentation by Regulatory Classification

Exhibit 2-14: Selected Thoracolumbar Spine Systems, 2000 

Exhibit 2-15: Selected Cervical Spine Systems, 2000 

Exhibit 2-16: Current Procedural Terminology Codes for Spinal Instrumentation

Exhibit 2-17: Common Coding Scenarios for Instrumented Spinal Fusions

Exhibit 2-18: Spinal Fusions, Mean Payments by Type and Payer, 1997-1999

Exhibit 2-19: Traditional Spine Instrumentation, Market Forecast, 1998-2005

Exhibit 2-20: Traditional Cervical Instrumentation, Market Forecast, 1998-2005 

Exhibit 2-21: Traditional Thoracic Instrumentation, Market Forecast, 1998-2005

Exhibit 2-22: Traditional Lumbar Instrumentation, Market Forecast, 1998-2005 

Exhibit 2-23: Traditional Instrumentation, Supplier Shares, 1999 and 2000 

Exhibit 2-24: Comparison of Materials Used for Interbody Fusion Devices 

Exhibit 2-25: Interbody Fusion Device Designs

Exhibit 2-26: Approaches and Techniques Used for Interbody Fusion Devices

Exhibit 2-27: Reasons for Failure of Interbody Fusion Device Procedures 

Exhibit 2-28: Selected Interbody Fusion Devices, 2000

Exhibit 2-29: Spinal Fusions Using Interbody Fusion Devices, 1998-2005 

Exhibit 2-30: Interbody Fusion Devices, Market Forecast, 1998-2005 

Exhibit 2-31: Cervical Interbody Fusion Devices, Market Forecast, 1998-2005 

Exhibit 2-32: Thoracic Interbody Fusion Devices, Market Forecast, 1998-2005 

Exhibit 2-33: Lumbar Interbody Fusion Devices, Market Forecast, 1998-2005 

Exhibit 2-34: Interbody Fusion Devices, Supplier Shares, 1999 and 2000

Exhibit 2-35: Selected Bone Supply and Processing Agreements, 2000 

Exhibit 2-36: Selected Bone Dowels and Allograft Implants, 2000 

Exhibit 2-37: Spinal Fusions Using Allograft Implants, Forecast, 1998-2005

Exhibit 2-38: Bone Dowels and Allograft Implants, Market Forecast, 1998-2005 

Exhibit 2-39: Allograft Implants by Type, Market Forecast, 1998-2005

Exhibit 2-40: Allograft Implants, Supplier Shares, 1999 and 2000 

Exhibit 2-41: Endoscopic Spinal Fusion, Procedure Forecast, 1998-2005 

Exhibit 2-42: Endoscopic Spinal Fusion Products, Market Forecast, 1998-2005 

 

3.0 MINIMALLY INVASIVE DISKECTOMY

3.1 Microdiskectomy Techniques

3.1.1 Microlumbar Diskectomy 

3.1.2 Percutaneous Diskectomy

3.1.3 Endoscopic Diskectomy

3.1.4 Microendoscopic Diskectomy

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 Disk Removal Technologies 

3.6.2.1 Chemonucleolysis (Knoll Pharmaceuticals) 

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 Diskectomy

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 Procedure Forecasts

3.7.1 Minimally Invasive By Access 

3.7.2 By Disk Removal Technique 

3.8 Market Analysis 

3.8.1 Visualization and Access Devices

3.8.2 Disk Removal Devices

3.8.3 Supplier Shares 

 

Exhibit 3-1: Intervertebral Disk Illustrations 

Exhibit 3-2: Comparison of Minimally Invasive Diskectomy Techniques 

Exhibit 3-3: Advantages and Disadvantages of MI Diskectomy Techniques 

Exhibit 3-4: Indications for Minimally Invasive Diskectomy

Exhibit 3-5: Most Common Clinical Manifestations of Lumbar Disk Herniation 

Exhibit 3-6: Risks Associated with Minimally Invasive Diskectomy

Exhibit 3-7: Cost of Laminectomy versus Laparoscopic Lumbar Diskectomy

Exhibit 3-8: Product Options for Minimally Invasive Diskectomy

Exhibit 3-9: METRx System Outcomes Assessment Data 

Exhibit 3-10: Comparison of Disk Removal Techniques 

Exhibit 3-11: Diskectomy, Procedure Forecast by Type, 1998-2005 

Exhibit 3-12: MI Diskectomy Procedures by Visualization, 1998-2005

Exhibit 3-13: Percutaneous/Endoscopic Diskectomy by Removal, 1998-2005 

Exhibit 3-14: Minimally Invasive Diskectomy Products, Market Forecast, 1998-2005 

Exhibit 3-15: Visualization and Access Systems, Market Forecast, 1998-2005 

Exhibit 3-16: Disk Removal Devices, Market Forecast, 1998-2005

Exhibit 3-17: Minimally Invasive Diskectomy, Supplier Shares, 1999 and 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

4.2.4 Products and Suppliers

4.2.4.1 GenSci Regeneration Sciences/DePuy 

4.2.4.1.1 Product Features and Requirements

4.2.4.1.2 Product Formats

4.2.4.1.3 Clinical Experience

4.2.4.1.4 Regulatory Status

4.2.4.1.5 Distribution

4.2.4.1.6 Additional Products 

4.2.4.1.7 Litigation 

4.2.4.2 Interpore Cross International

4.2.4.2.1 Product Features 

4.2.4.2.2 Regulatory Status

4.2.4.2.3 Pricing and Distribution

4.2.4.3 Musculoskeletal Transplant Foundation/Synthes 

4.2.4.4 NeuColl/Zimmer 

4.2.4.4.1 Product Features 

4.2.4.4.2 Regulatory Status

4.2.4.4.3 Clinical Results

4.2.4.4.4 Reimbursement and Pricing

4.2.4.4.5 Distribution

4.2.4.5 Orquest/Sulzer

4.2.4.5.1 Product Features 

4.2.4.5.2 Regulatory Status

4.2.4.5.3 Clinical Results

4.2.4.5.4 Distribution

4.2.4.6 Orthovita 

4.2.4.6.1 Product Features 

4.2.4.6.2 Regulatory Status

4.2.4.6.3 Clinical Experience

4.2.4.6.4 Distribution

4.2.4.7 Osteotech 

4.2.4.7.1 Product Features 

4.2.4.7.2 Clinical Results

4.2.4.7.3 Strategic Alliances

4.2.4.7.4 Distribution

4.2.4.7.5 Litigation 

4.2.4.8 Regeneration Technologies/Sofamor Danek 

4.2.4.8.1 Product Requirements

4.2.4.8.2 Regulatory Status

4.2.4.8.3 Raw Material Supply 

4.2.4.8.4 Distribution

4.2.4.9 Wright Medical Technology

4.2.4.9.1 OsteoSet

4.2.4.9.2 AlloMatrix

4.2.4.9.3 Distribution

4.2.4.9.4 Litigation 

4.2.5 Procedure Forecasts 

4.2.6 Market Analysis

4.2.7 Supplier Shares 

4.2.7.1 Base Allograft 

4.2.7.2 Demineralized Bone Matrix 

4.2.7.3 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 Procurement

4.3.4.1.2 Regulatory Status

4.3.4.1.3 Advantages and Limitations 

4.3.4.1.4 Clinical Experience

4.3.4.1.5 Costs & Reimbursement 

4.3.4.1.6 Product Distribution 

4.3.4.2 Harvest Technologies/DePuy AcroMed 

4.3.4.2.1 SmartPReP Protocol 

4.3.4.2.2 Regulatory Status & Indications 

4.3.4.2.3 Advantages and Limitations 

4.3.4.2.4 Clinical Experience

4.3.4.2.5 Costs & Reimbursement 

4.3.4.2.6 Product Distribution 

4.3.5 Bone Morphogenetic Proteins (BMPs) 

4.3.5.1 Sofamor Danek/Genetics Institute

4.3.5.1.1 InFUSE 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 Reimbursement

4.3.5.1.6 Pricing and Distribution

4.3.5.1.7 Alternative Carrier 

4.3.5.2 Stryker/Curis 

4.3.5.2.1 OP-1 Product Description

4.3.5.2.2 Product Rights 

4.3.5.2.3 Advantages and Limitations 

4.3.5.2.4 Clinical Experience

4.3.5.2.5 Regulatory Status and Trials

4.3.5.2.6 Pricing 

4.3.5.2.7 Reimbursement

4.3.5.2.8 Distribution

4.3.5.3 Orquest/Biopharm GmbH 

4.3.5.3.1 Product Background 

4.3.5.3.2 Clinical Experience

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/Chrysalin BioTechnology 

4.3.7.1.1 Chrysalin Overview

4.3.7.1.2 Regulatory Status

4.3.7.1.3 Pricing 

4.3.7.1.4 Other Applications

4.3.7.2 Sulzer Biologics 

4.3.7.2.1 Neo-Osteo Product Description 

4.3.7.2.2 Clinical Experience

4.3.7.2.3 Additional Applications

4.3.7.3 Osiris Therapeutics

4.3.8 Procedure Forecast

4.3.9 Market Analysis

 

Exhibit 4-1: Design Criteria for “Ideal” Bone Graft Product

Exhibit 4-2: Types and Features of Bone Graft Materials 

Exhibit 4-3: Selected Demineralized Bone Matrix Products, 2000

Exhibit 4-4: Selected Synthetic Bone Graft Substitutes, 2000

Exhibit 4-5: Bone Graft Substitutes, Procedure Forecast, 1998-2005

Exhibit 4-6: Bone Graft Substitutes, Market Forecast, 1998-2005 

Exhibit 4-7: Base Allograft, Supplier Shares, 1999 and 2000 

Exhibit 4-8: Demineralized Bone Matrix, Product Shares, 1999 and 2000

Exhibit 4-9: Synthetic Bone Substitutes, Supplier Shares, 1998-2005

Exhibit 4-10: Selected Bone Growth Factors, 2000

Exhibit 4-11: Advantages and Limitations of InFUSE (rhBMP-2)

Exhibit 4-12: Bone Growth Factors, Procedure Forecast, 1998-2005

Exhibit 4-13: Bone Growth Factors, 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 Disks

5.3.1 Approaches 

5.3.1.1 Total Disk 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 Disk Products 

5.3.3.1 DePuy AcroMed

5.3.3.1.1 Product Description 

5.3.3.1.2 Clinical Experience

5.3.3.1.3 Implantation

5.3.3.1.4 Regulatory Status

5.3.3.2 Disk Replacement Technologies 

5.3.3.3 Frenchay Hospital 

5.3.3.4 Interpore Cross International

5.3.3.5 Link Spine Group

5.3.3.5.1 Background 

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

5.3.3.5.7 Pricing 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 Description 

5.3.3.9.2 Implantation

5.3.3.9.3 Clinical Experience

5.3.3.9.4 Regulatory Status

5.3.3.9.5 Additional Products 

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 and Contraindications

5.3.4.4.5 Clinical Experience

5.3.4.4.6 Regulatory Status

5.3.4.4.7 Pricing and Reimbursement

5.3.4.4.8 Distribution

5.3.4.5 Stryker Howmedica Osteonics/Stryker Spine

5.3.4.5.1 Implantation

5.3.4.5.2 Clinical Experience

5.3.4.6 Sulzer Medica 

5.3.5 Procedure and Market Forecasts 

5.4 Disk 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 Products, Market Forecast, 1998-2005 

Exhibit 5-5: Total Disk Replacement versus Nucleus Replacement 

Exhibit 5-6: Selected Disk Replacement Products and Programs, 2000 

Exhibit 5-7: Selected Nucleus Replacement Products and Programs, 2000

Exhibit 5-8: Indications & Contraindications for the Prosthetic Disc Nucleus 

Exhibit 5-9: Artificial Disks Products, Market Forecast, 2004 and 2005

Exhibit 5-10: Gene Therapy Delivery Options 

Exhibit 5-11: Selected Disk 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: Distribution Alliances for Spinal Bone Growth Stimulators, 2000 

Exhibit 6-4: Spinal Bone Growth Stimulation, Patient Forecast, 1998-2005

Exhibit 6-5: Spinal Bone Growth Stimulators, Market Forecast, 1998-2005

Exhibit 6-6: Spinal Bone Growth Stimulators, Supplier Shares, 1999 and 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 Reimbursement Issues 

7.6 Products

7.6.1 Accuray Oncology 

7.6.1.1 Planning System

7.6.1.2 Image Guided System 

7.6.1.3 Approval and Installation Sites 

7.6.2 Armstrong Healthcare Limited 

7.6.2.1 EndoAssist 

7.6.2.2 PathFinder 

7.6.3 Brock Rogers Surgical 

7.6.4 Computer Motion

7.6.4.1 ZEUS Robotic Surgical System 

7.6.4.2 AESOP

7.6.5 Fraunhofer Gesellschaft 

7.6.5.1 RoMed Robot

7.6.5.2 Marketing and Approval 

7.6.6 Institut fur Angewandte Informatik

7.6.7 Integrated Surgical Systems

7.6.8 Intuitive Surgical 

7.6.8.1 InSite Visualization System 

7.6.8.2 Endo Wrist Technology

7.6.8.3 Applications and Approvals 

7.6.9 jojumarie Intelligente Instrumente GmbH

7.6.9.1 Components 

7.6.9.2 Surgical Procedure 

7.6.10 Micro Dexterity Systems 

7.6.10.1 RAMS Prototype Robot 

7.6.10.1.1 Mechanical Subsystem 

7.6.10.1.2 Electronic Subsystem

7.6.10.1.3 Servo-Control Subsystem

7.6.10.1.4 Software Subsystem

7.6.10.2 NeuroDex and MicroDex 

7.6.10.3 Approval and Cost 

7.6.11 ortoMaquet 

7.6.11.1 CASPAR System 

7.6.11.2 Finite-Element Method 

7.6.11.3 Regulatory Status and Cost 

7.6.12 Universal Robot Systems 

7.6.13 University of California at Berkley

7.6.13.1 Components 

7.6.13.2 Tactile Feedback Device 

7.6.13.3 Approval and Marketing 

7.6.14 Zeiss

7.7 Market Analysis 

7.7.1 Low End Systems 

7.7.2 High End Systems

7.7.3 Supplier Shares 

 

Exhibit 7-1: Types of Surgical Robotics

Exhibit 7-2: Selected Robotic Systems with Potential Application to the Spine, 2000

Exhibit 7-3: CyberKnife System 

Exhibit 7-4: EndoAssist Mechanical Assist Device

Exhibit 7-5: Computer Motion ZEUS and AESOP Systems 

Exhibit 7-6: ARTEMIS Robotic System 

Exhibit 7-7: DaVinci Robotic System 

Exhibit 7-8 Diagram of MicroDexterity RAMS Device

Exhibit 7-9: Universal Robot Systems Evolution 1 

Exhibit 7-10: Spinal Robotic Systems, Market Forecast by Type. 1998-2005

Exhibit 7-11: Spinal Robotic Systems, Supplier Shares, 1999 and 2000 

 

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 Procedure Cost and 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 (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 Procedure Cost 

8.3.2.5 Patient Profile

8.3.2.6 Advantages and Limitations

8.3.2.7 Clinical Experience 

8.3.2.8 Regulatory Status 

8.3.2.9 Reimbursement 

8.3.2.10 Product Launch and Training 

8.3.2.11 Product Distribution 

8.3.2.12 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 Procedure and Product Coding for Reimbursement

8.3.3.8 Vertebral Body Replacement Devices

8.3.3.8.1 DePuy AcroMed 

8.3.3.8.2 Interpore Cross 

8.3.3.8.3 Osteotech

8.4 Procedure Forecasts

8.5 Market Analysis 

8.5.1 Bone Cements

8.5.2 Kyphoplasty Products 

8.5.3 Vertebral Body Replacement Devices

 

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: CPT Codes for Vertebroplasty

Exhibit 8-5: Selected Bone Cements, 2000 

Exhibit 8-6: Advantages and Limitations of Kyphoplasty

Exhibit 8-7: Indications for Vertebral Body Replacement

Exhibit 8-8: Cancers With Probable Bone Metastases, 2000

Exhibit 8-9: Contraindications for Vertebral Body Replacement 

Exhibit 8-10: Potential Complications Associated with Vertebral Body Replacement

Exhibit 8-11: Selected Vertebral Body Replacement Devices, 2000 

Exhibit 8-12: Vertebral Fracture/Tumors, Procedure Forecast, 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: Bone Cements, Supplier Shares, 1999 and 2000 

Exhibit 8-16: Kyphoplasty Bone Tamps and Devices, Market Forecast, 1998-2005

Exhibit 8-17: Vertebral Body Replacement Devices, Market Forecast, 1998-2005

 

9.0 COMPANY PROFILES 

9.1 B. Braun Melsungen AG (Aesculap) 

9.2 Biolectron

9.3 Biomet/EBI

9.4 Clarus Medical Systems 

9.5 Coherent 

9.6 Computer Motion 

9.7 Encore Medical Corporation

9.8 Endius

9.9 GenSci Regeneration Sciences 

9.10 Implex Corporation 

9.11 Integrated Surgical Systems

9.12 Interpore Cross International 

9.13 Intuitive Surgical 

9.14 Johnson & Johnson (DePuy AcroMed, Codman & Shurtleff)) 

9.15 Kyphon

9.16 Laserscope

9.17 Medtronic Sofamor Danek 

9.18 NeuColl 

9.19 ORATEC Interventions 

9.20 Orquest 

9.21 Orthofix International 

9.22 OrthoLogic 

9.23 Orthovita 

9.24 Osteotech

9.25 Raymedica 

9.26 Regeneration Technologies 

9.27 Smith & Nephew plc (Dyonics, Exogen)

9.28 Stellar Medical 

9.29 Stryker Corporation (Howmedica Osteonics) 

9.30 Sulzer Medica Ltd. (Spine-Tech)

9.31 Synthes-Stratec

9.32 Trimedyne 

9.33 Tyco International Ltd. (Surgical Dynamics) 

9.34 Waldemar Link GmbH & Company

9.35 Wright Medical Corporation

 

APPENDIX: COMPANY LIST