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U.S. Markets for Adjunctive and Non-Fusion Spine Technologies

Published January 2003 | 490 Pages | 125 Exhibits | Forecasts Through 2008


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Companies Covered

ArthroCare Corporation 

Biorthex, Inc. 

Centerpulse AG (Spine-Tech)

Clarus Medical, LLC 

Endius, Inc. 

Interpore Cross International, Inc. 

Johnson & Johnson (Codman & Shurtleff, DePuy AcroMed) 

Kyphon, Inc

Link Spine Group, Inc

Medtronic, Inc. (Sofamor Danek)

Mekanika, Inc. 

Orthovita, Inc. 

Osteotech, Inc. 

Parallax Medical, Inc. 

Raymedica, Inc. 

Smith & Nephew, plc

Spine Solutions, Inc. 

Spine Wave, Inc. 

St. Francis Medical Technologies, Inc

Stryker Corporation (Howmedica Osteonics, Surgical Dynamics) 

Synthes-Stratec, Inc. 

Trimedyne, Inc.

Vertis Neuroscience, Inc.

Table of Contents


Expanding Treated Patient Population

Total Market Opportunity 

Minimally Invasive Discectomy

Interventional Pain Management 

Management of Vertebral Fractures and Tumors 

Prosthetic Discs

Other Emerging Fusion Alternatives 


Summary Exhibit 1: Non-Fusion Technologies, Procedure Forecast, 2001-2008

Summary Exhibit 2: Non-Fusion Technologies, Market Forecast, 2001-2008 

Summary Exhibit 3: Minimally Invasive Discectomy, Procedure and Market Forecast, 2001-2008

Summary Exhibit 4: Interventional Pain Management, Procedure and Market Forecast, 2001-2008

Summary Exhibit 5: Vertebral Fracture Management, Procedure and Market Forecast, 2001-2008

Summary Exhibit 6: Overview of Near Term Prosthetic Disc Programs 

Summary Exhibit 7: Prosthetic Discs, Procedure and Market Forecast, 2004-2008 

Summary Exhibit 8: Flexible Stabilization, Procedure and Market Forecast, 2004-2008 



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 Degenerative Disc Disease Prevalence Symptoms and Diagnosis Treatment Herniated Disc Types Symptoms and Diagnosis Prevalence Treatment Spinal Stenosis Symptoms and Diagnosis Treatment Spondylosis Prevalence Symptoms and Diagnosis Treatment Spondylolisthesis Prevalence Types Diagnosis Treatment Osteoporosis Prevalence Types Risk Factors Diagnosis Treatment Osteoarthritis Prevalence Risk Factors Diagnosis Treatment Rheumatoid Arthritis 

1.2.2 Spinal Trauma Cervical, Thoracic and Lumbar Trauma Spinal Cord Trauma

1.2.3 Deformity Disorders Scoliosis Symptoms Diagnosis Treatment Kyphosis Symptoms Diagnosis Treatment Lordosis

1.2.4 Spinal Tumors Malignant Spinal Tumors 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 



2.1 Microdiscectomy Techniques 

2.1.1 Microlumbar Discectomy 

2.1.2 Percutaneous Discectomy 

2.1.3 Endoscopic Discectomy

2.1.4 Microendoscopic Discectomy

2.2 Indications

2.3 Patient Profile

2.4 Complications 

2.5 Procedure Costs 

2.6 Products and Technology

2.6.1 Visualization and Access Products Biomet/EBI Blackstone Medical Clarus Medical Endius Myelotec (Clarus Medical) NuVasive Sofamor Danek Spinal Concepts Surgical Dynamics (Stryker) Richard Wolf Medical Instruments

2.6.2 Disc Removal Technologies Chemonucleolysis Manual and Powered Systems Endius HydroCision Pain Concepts (Stryker) Sofamor Danek Surgical Dynamics (Stryker) Electrothermal (ArthroCare) Laser-Assisted Discectomy Clarus Medical EKL Medical Laserscope Lumenis Trimedyne High Intensity Focused Ultrasound 

2.6.3 Product Trends: Annulus Repair Anulex Technologies Intrinsic Therapeutics SpinaLabs Spine Partners 

2.7 Procedure Forecasts 

2.8 Market Analysis 

2.9 Competitive Analysis


Exhibit 2-1: Intervertebral Disc Illustrations 

Exhibit 2-2: Comparison of Minimally Invasive Discectomy Techniques

Exhibit 2-3: Advantages and Disadvantages of Minimally Invasive Discectomy Techniques 

Exhibit 2-4: Indications for Minimally Invasive Discectomy

Exhibit 2-5: Most Common Clinical Manifestations of Lumbar Disc Herniation

Exhibit 2-6: Risks Associated with Minimally Invasive Discectomy 

Exhibit 2-7: Cost of Laminectomy versus Laparoscopic Lumbar Discectomy 

Exhibit 2-8: Current and Emerging Product Options for Minimally Invasive Discectomy, 2003 

Exhibit 2-9: Biomet/EBI's VueCath Spinal Endoscopic System 

Exhibit 2-10: Blackstone Medical's Discectomy Products

Exhibit 2-11: Endius' Atavi System 

Exhibit 2-12: The METRx System 

Exhibit 2-13: METRx System Outcomes Assessment Data 

Exhibit 2-14: Spinal Concepts' Access Dilatation Port 

Exhibit 2-15: The Yeung Endoscopic Spine Surgery (YESS) System 

Exhibit 2-16: Comparison of Disc Removal Techniques 

Exhibit 2-17: Endius' MDS MicroDebrider System

Exhibit 2-18: Pain Concepts' Dekompressor Percutaneous Discectomy Probe 

Exhibit 2-19: Selected ArthroCare Nucleoplasty Products

Exhibit 2-20: Selected Laser Systems Utilized in Discectomy

Exhibit 2-21: Clarus Medical's LASE System 

Exhibit 2-22: Trimedyne OmniTip Laser Needle Technology

Exhibit 2-23: Early Stage Annulus Repair Technologies 

Exhibit 2-24: Discectomies, Procedure Forecast, 2001-2008

Exhibit 2-25: Minimally Invasive Diskectomies by Approach and Disc Removal Technology, 2001-2008 

Exhibit 2-26: Minimally Invasive Discectomy Products, Market Forecast, 2001-2008

Exhibit 2-27: Minimally Invasive Discectomy Products, Supplier Shares, 2002



3.1 Traditional Approaches

3.1.1 Drug Therapy

3.1.2 Injections

3.1.3 Epiduroscopy 

3.1.4 Spinal Cord Stimulation

3.1.5 Spinal Infusion Pump

3.2 Intradiscal Heating

3.2.1 IntraDiscal ElectroThermal Therapy (Smith & Nephew) Product IDET Procedure Clinical Experience Indications and Benefits Regulatory Status Pricing & Reimbursement Distribution Additional Products 

3.2.2 Radiofrequency Annuloplasty (Radionics) Product Procedure Clinical Experience Indications and Benefits Regulatory Status 

3.2.3 Procedure Forecasts 

3.2.4 Market Analysis 

3.3 Percutaneous Neuromodulation Therapy

3.3.1 Product 

3.3.2 PNT Procedure

3.3.3 Clinical Experience

3.3.4 Indications and Benefits

3.3.5 Regulatory Status 

3.3.6 Pricing & Reimbursement

3.3.7 Distribution 

3.3.8 Procedure and Market Forecasts

3.4 Intradiscal Hypothermia Therapy 

3.4.1 Clinical Rationale

3.4.2 Product 

3.4.3 Procedure 

3.4.4 Indications and Benefits

3.4.5 Regulatory Status 


Exhibit 3-1: Emerging Approaches to Interventional Pain Management 

Exhibit 3-2: Traditional Pain Management Approaches

Exhibit 3-3: Smith & Nephew's IDET Technology 

Exhibit 3-4: IDET: Long-Term Clinical Improvements 

Exhibit 3-5: Randomized, Double-Blinded, Placebo Controlled IDET Trial Results 

Exhibit 3-6: Overview of IntraDiscal ElectroThermal Therapy 

Exhibit 3-7: The Smith & Nephew Decompression Catheter

Exhibit 3-8: Radionics' discTRODE Technology for RF Annuloplasty 

Exhibit 3-9: Overview of discTRODE RF Annuloplasty 

Exhibit 3-10: Thermal Therapy, Procedure Forecast, 2001-2008

Exhibit 3-11: Thermal Therapy Products, Market Forecast, 2001-2008 

Exhibit 3-12: Thermal Therapy Market Shares, 2002 

Exhibit 3-13: The Vertis PNT System 

Exhibit 3-14: Summary of Clinical Studies Forming the Basis for the Vertis PNT System 

Exhibit 3-15: Overview of Percutaneous Neuromodulation Therapy (PNT) 

Exhibit 3-16: PNT Patient and Procedure Forecast, 2002-2008 

Exhibit 3-17: PNT Market Forecast, 2002-2008



4.1 Indications

4.1.1 Osteoporotic Compression Fractures

4.1.2 Vertebral Trauma Fractures 

4.1.3 Malignant Spinal Tumors 

4.1.4 Spinal Hemangiomas 

4.2 Clinical Goals of Therapy

4.3 Techniques 

4.3.1 Vertebroplasty Technique Setting and Specialties Clinical Experience Pain Relief Outcomes Stabilization Outcomes Complications Product Requirements Contraindications Procedure Cost and Reimbursement Regulatory Issues Bone Cements Biomet Merck/ScandiMed Codman & Shurtleff (Johnson & Johnson) DePuy AcroMed (Johnson & Johnson) Howmedica Osteonics (Stryker) Interpore Cross International Mitsubishi Materials Corporation Orthovita Parallax Medical, Inc. Regeneration Technologies Smith & Nephew Synthes USA (Norian) Zimmer Delivery Systems Biomet Merck Cook I-Flow Corporation Interpore Cross International Parallax Medical Stryker Instruments

4.3.2 Kyphoplasty Technique Setting and Specialties Product Requirements Procedure Cost Patient Profile Advantages and Limitations Contraindications Clinical Experience Cleveland Clinic Foundation Retrospective Multicenter Study Role of Fracture Age Sagittal Angulation of Spine Restoration of Vertebral Height Restoration of Mechanical Strength Incidence of Adjacent Fracture Use in Osteolytic Disease and Cancer Complications Regulatory Status Reimbursement Product Launch and Training Product Distribution Emerging Applications for Kyphoplasty Products 

4.3.3 Vertebral Body Replacement Technique Indications Contraindications Complications Product Requirements Clinical Experience Procedure and Product Reimbursement Vertebral Body Replacement Devices Biomet/Biomet Merck Biorthrex DePuy AcroMed Implex Interpore Cross International Osteotech Sofamor Danek Surgical Dynamics (Stryker) Synthes USA

4.4 Procedure Forecasts 

4.5 Market Analysis 

4.5.1 Bone Cements 

4.5.2 Cement Delivery Systems

4.5.3 Kyphoplasty Products 

4.5.4 Vertebral Body Replacement Devices 


Exhibit 4-1: Major Indications for Vertebral Intervention

Exhibit 4-2: Techniques for Managing Vertebral Fractures and Tumors 

Exhibit 4-3: Approaches to Spine for Vertebroplasty

Exhibit 4-4: Vertebral Compression Fracture Pre- and Post-Treatment

Exhibit 4-5: Complications Associated with Vertebroplasty

Exhibit 4-6: Contraindications to Vertebroplasty 

Exhibit 4-7: Selected Reimbursement Codes for Vertebroplasty 

Exhibit 4-8: ICD-9 Codes that Support Medical Necessity for Vertebroplasty

Exhibit 4-9: Selected Bone Cements, 2003

Exhibit 4-10: Selected Percutaneous Bone Cement Delivery Systems, 2003 

Exhibit 4-11: Kyphoplasty Procedure

Exhibit 4-12: KyphX Kyphoplasty System

Exhibit 4-13: Advantages and Limitations of Kyphoplasty

Exhibit 4-14: Indications for Vertebral Body Replacement 

Exhibit 4-15: Cancers With Probable Bone Metastases, 2003 

Exhibit 4-16: Contraindications for Vertebral Body Replacement

Exhibit 4-17: Potential Complications Associated with Vertebral Body Replacement

Exhibit 4-18: Selected Vertebral Body Replacement Devices, 2003 

Exhibit 4-19: Biomet Merck Vertebral Body Replacement Devices

Exhibit 4-20: DePuy Acromed Vertebral Body Replacement Devices 

Exhibit 4-21: Interpore Cross International Vertebral Body Replacement Devices

Exhibit 4-22: Osteotech VBR Device 

Exhibit 4-23: Sofamor Danek Verte-Span Vertebral Body Replacement Device 

Exhibit 4-24: Synthes' Synex Spacer

Exhibit 4-25: Vertebral Fracture Management, Procedure Forecast, 2001-2008 

Exhibit 4-26: Vertebral Fracture Management Products, Market Forecast, 2001-2008

Exhibit 4-27: Vertebroplasty and Kyphoplasty Bone Cement, Market Forecast, 2001-2008 

Exhibit 4-28: Vertebroplasty and Kyphoplasty Bone Cements, Supplier Shares, 2002

Exhibit 4-29: Bone Cement Delivery Kits, Market Forecast, 2001-2008

Exhibit 4-30: Bone Cement Delivery Kits, Supplier Shares, 2002

Exhibit 4-31: Kyphoplasty Bone Tamps and Accessories, Market Forecast, 2001-2008 

Exhibit 4-32: Vertebral Body Replacement Devices, Market Forecast, 2001-2008

Exhibit 4-33: Vertebral Body Replacement Devices, Supplier Shares, 2002



5.1 Approaches 

5.1.1 Total Disc Replacement Technology Indications

5.1.2 Nucleus Replacement Technology Indications

5.2 Implantation Techniques

5.2.1 Total Disc Implantation 

5.2.2 Nucleus Implantation 

5.3 Regulatory Issues 

5.4 Total Prosthetic Disc Products

5.4.1 AxioMed Spine Clinical Rationale Product Description Indications and Contraindications Clinical Path

5.4.2 Biorthex

5.4.3 DePuy AcroMed Acroflex Product Description Clinical Experience Disc Replacement Technologies Next Generation Programs

5.4.4 Hokkaido University

5.4.5 Link Spine Group Background Product Description Implantation Indications Clinical Experience Regulatory Status Pricing and Distribution Additional Products 

5.4.6 Pearsalls 

5.4.7 ReGen Biologics 

5.4.8 Scient'x 

5.4.9 Sofamor Danek (Medtronic) Maverick Prestige Spinal Dynamics Product Description Implantation Clinical Experience Regulatory Status 

5.4.10 SpineCore

5.4.11 Spine Solutions Product Description Implantation Clinical Experience Regulatory Status 

5.4.12 Other Potential Programs SaluMedica Spine Partners Stryker/Surgical Dynamics 

5.5 Nucleus Replacement Products

5.5.1 Aberdeen Orthopaedic Developments 

5.5.2 Centerpulse Spine-Tech Product Description Implantation Indications and Benefits Clinical Experience Regulatory Status 

5.5.3 CryoLife

5.5.4 Disc Dynamics Implantation Clinical Status 

5.5.5 Dynamic Spine

5.5.6 Gelifex Inc. Product Description Implantation Clinical Status 

5.5.7 Li Medical

5.5.8 Mathys Medical 

5.5.9 Raymedica Product Description Implantation Posterior ALPA Learning Curve Complications Indications and Contraindications Clinical Experience Regulatory Status Pricing and Reimbursement Distribution 

5.5.10 Replication Medical 

5.5.11 Spine Wave 

5.5.12 Stryker Howmedica Osteonics Implantation Clinical Experience

5.6 Market Analysis 

5.6.1 Procedure Forecasts 

5.6.2 Market Forecasts

5.6.3 Competitive Analysis


Exhibit 5-1: Total Disc Replacement versus Nucleus Replacement

Exhibit 5-2: Overview of Indication Criteria for Total Disc Replacement

Exhibit 5-3: Selected Total Disc Replacement Products, 2003 

Exhibit 5-4: The Acroflex Artificial Disc 

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

Exhibit 5-6: Sofamor Danek's Disc Replacement Technologies

Exhibit 5-7: SpineCore's FlexiCore Intervertebral Disc

Exhibit 5-8: Spine Solutions' ProDisc 

Exhibit 5-9: Other Potential Total Disc Replacement Programs 

Exhibit 5-10: Selected Nucleus Replacement Products and Programs, 2003

Exhibit 5-11: Centerpulse Spine-Tech's Newcleus Implant

Exhibit 5-12: Injection of CryoLife's BioDisc 

Exhibit 5-13: Raymedica’s PDN Prosthetic Disc Nucleus 

Exhibit 5-14: Indications & Contraindications for the Prosthetic Disc Nucleus 

Exhibit 5-15: Market Drivers and Concerns of Prosthetic Disc Products 

Exhibit 5-16: Prosthetic Disc Products, Procedure Forecast, 2004-2008 

Exhibit 5-17: Prosthetic Disc Products, Market Forecast, 2004-2008



6.1 Flexible Stabilization 

6.1.1 CISAD (Mekanika) Product Description Indications Adjunctive Technology Regulatory Status Distribution 

6.1.2 DYNESYS (Centerpulse Spine-Tech) Product Description Implantation Indications and Benefits Clinical Experience Regulatory Status 

6.1.3 Fulcrum-Assisted Soft Stabilization (FASS)

6.1.4 Graf Ligamentoplasty Indications and Benefits Clinical Experience

6.1.5 Leeds-Keio Ligamentoplasty

6.1.6 Orthobiom (Biorthex) 

6.1.7 Staple/Tether Approach (Sofamor Danek) 

6.1.8 Wallis System (Clinique Saint Martin/Biomet Merck) Product Description Indications and Benefits Clinical Experience Regulatory Status 

6.1.9 X STOP (St. Francis Medical Technologies) Product Description Indications Implantation Clinical Experience Regulatory Status 

6.1.10 Market Analysis 

6.2 Facet Joint Arthroplasty

6.2.1 Clinical Rationale

6.2.2 Patient Population 

6.2.3 Artificial Facet Joint Products Archus Orthopedics Fitz Artificial Facet Joint Martin Vertebral Joint Facets Prostheses MedicineLodge (Fallin Joint Prosthesis) 

6.3 Extra-Ligamentous Repair 

6.3.1 Clinical Rationale

6.3.2 Technology 

6.4 Spinal Biologics: Disc Regeneration & Resorption

6.4.1 Primer on Gene Therapy Gene Selection Delivery Vehicles Delivery Approaches 

6.4.2 Clinical Goals of Discal Gene Therapy Nucleus Pulposus Regeneration co.don Tissue Engineering Emory University TEI Biosciences (Sofamor Danek) University of Chicago University of Pennsylvania University of Pittsburgh Total Disc Restoration (Rush Medical College) Disc Resorption (Vanderbilt University) 


Exhibit 6-1: Overview of Emerging Fusion Alternatives 

Exhibit 6-2: Selected Technologies for Flexible Stabilization, 2003 

Exhibit 6-3: Mekanika's CISAD System

Exhibit 6-4: Centerpulse Spine-Tech's DYNESYS System

Exhibit 6-5: FASS System 

Exhibit 6-6: The Graf System 

Exhibit 6-7: Indications & Contraindications for Graf Ligamentoplasty 

Exhibit 6-8: The Wallis System 

Exhibit 6-9: The X STOP Interspinous Process Distraction System 

Exhibit 6-10: Preliminary Results from the X STOP IPD Pivotal IDE Clinical Trial

Exhibit 6-11: Flexible Stabilization Procedure and Market Forecast, 2004-2008

Exhibit 6-12: Selected Early Stage Facet Joint Replacement Programs, 2003

Exhibit 6-13: Gene Therapy Delivery Options 

Exhibit 6-14: Selected Disc Regeneration Programs, 2003



7.1 ArthroCare Corporation 

7.2 Biorthex, Inc. 

7.3 Centerpulse AG (Spine-Tech)

7.4 Clarus Medical, LLC 

7.5 Endius, Inc. 

7.6 Interpore Cross International, Inc. 

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

7.8 Kyphon, Inc

7.9 Link Spine Group, Inc

7.10 Medtronic, Inc. (Sofamor Danek)

7.11 Mekanika, Inc. 

7.12 Orthovita, Inc. 

7.13 Osteotech, Inc. 

7.14 Parallax Medical, Inc. 

7.15 Raymedica, Inc. 

7.16 Smith & Nephew, plc

7.17 Spine Solutions, Inc. 

7.18 Spine Wave, Inc. 

7.19 St. Francis Medical Technologies, Inc

7.20 Stryker Corporation (Howmedica Osteonics, Surgical Dynamics) 

7.21 Synthes-Stratec, Inc. 

7.22 Trimedyne, Inc.

7.23 Vertis Neuroscience, Inc.




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