U.S. MARKETS FOR IMAGE-GUIDED SURGERY PRODUCTS

EXECUTIVE SUMMARY

i. Currently Available Versions of Image-Guided Surgery Techniques

ii. Established Clinical Applications of Image-Guided Surgery

iii. Clinical Benefits of Image-Guided Surgery

iv. Adoption Issues and Trends

v. Image-Guided Surgery Products Market

vi. Interventional Imaging Systems Market

vii. Surgical Navigation Systems Market

Exhibit ES-1: Advantages and Disadvantages of Image-Guided Surgery Techniques

Exhibit ES-2: Selected Clinical Applications of Image-Guided Surgery Techniques

Exhibit ES-3: Image-Guided Surgery Products, Market Forecast, 2004-2009

Exhibit ES-4: Interventional and Surgical Imaging, Procedure Volumes Forecast, 2004-2009

Exhibit ES-5: Interventional and Surgical Imaging Systems, Market Forecast, 2004-2009

Exhibit ES-6: Image Guided Surgery, Procedure Volumes Forecast, by Surgical Area, 2004-2009

Exhibit ES-7: Surgical Navigation Systems, Market Forecast, 2004-2009

1. IMAGE-GUIDED SURGERY OVERVIEW

1.1 Technology

1.2 Clinical Benefits

1.3 Adoption Issues and Trends

1.3.1 Impact of Managed Care

1.3.2 Reimbursement

1.3.3 End-User Perspectives

Exhibit 1-1: Advantages and Disadvantages of Image-Guided Surgery Techniques

Exhibit 1-2: Clinical Applications of Image-Guided Surgery Techniques

Exhibit 1-3: Definition of Medical Necessity

Exhibit 1-4: Considerations Influencing Reimbursement Policies for Computer-Assisted Image-Guided Surgery

Exhibit 1-5: Considerations Influencing the Adoption of Computer-Assisted Image-Guided Surgery by End-Users

2. ESTABLISHED CLINICAL APPLICATIONS OF IMAGE-GUIDED SURGERY

2.1 Cardiovascular Transcatheter Interventions

2.1.1 Angioplasty and Stenting

2.1.2 Laser Atherectomy

2.1.3 Mechanical Atherectomy

2.1.4 CryoPlasty

2.1.5 Catheter-Directed Thrombolysis

2.1.6 Mechanical Thrombectomy

2.1.7 Vena Cava Filter Placement

2.1.8 Device-Based Endovascular Embolization

2.1.9 Endovascular Repair of Aortic Aneurysms

2.1.10 Transcatheter Cardiac Arrhythmia Ablation

2.2 Neurosurgery

2.2.1 Issues and Trends

2.2.1.1 Stereotaxy

2.2.1.1.1 Frame-Based Stereotaxy

2.2.1.1.2 Frameless Stereotaxy

2.2.1.2 Brain Shift Compensation

2.2.2 Common Image-Guided Neurosurgical Procedures

2.2.2.1 Central Nervous System Tumor Resection

2.2.2.2 Cerebrospinal Fluid Shunting and Drainage in Hydrocephalus

2.2.2.3 Aneurysm/Arterial Venous Malformation Repair and Surgical Clipping

2.2.2.4 Epilepsy Surgery

2.2.2.5 Deep Brain Stimulation in Parkinson's Disease

2.3 Otolaryngology

2.3.1 Image-Guided Functional Endoscopic Sinus Surgery

2.4 Orthopedics

2.4.1 Total Joint Arthroplasty

2.4.1.1 Hip Replacement

2.4.1.2 Knee Replacement

2.4.1.2.1 Unicompartmental Knee Replacement

2.4.1.3 Computer-Assisted/Image-Guided Techniques in Total Joint Surgery

2.4.2 Computer-Assisted High Tibial Osteotomy

2.4.3 Image-Guided Techniques for Complex Fracture Repair

2.5 Spinal Surgery

2.5.1 Common Spinal Surgery Procedures

2.5.1.1 Discectomy

2.5.1.2 Laminectomy and Laminotomy

2.5.1.3 Spinal Fusion

2.5.1.3.1 Instrumented Fusion

2.5.2 Image-Guided Spinal Surgery Techniques

2.5.2.1 Pedicle Screw Placement

2.6 Image-Guided Biopsy

2.6.1 Clinical Issues and Trends

2.6.1.1 Diagnostic Accuracy

2.6.2 Image-Guided Biopsy Procedures

2.6.2.1 Fine Needle Aspiration

2.6.2.2 Core Needle Biopsy

2.6.2.3 Cone Biopsy

2.6.2.4 Endoscopic Biopsy

2.6.2.5 Punch Biopsy

2.6.2.6 Surgical Biopsy

2.6.2.7 Procedure Volumes

2.6.2.7.1 Breast Biopsy

2.6.2.7.2 Liver Biopsy

2.6.2.7.3 Prostate Biopsy

2.6.2.7.4 Sentinel Node Biopsy

2.6.3 Products

2.6.3.1 Computed Tomography-Guided Biopsy

2.6.3.2 Fluoroscopy-Guided Biopsy

2.6.3.3 Interventional Magnetic Resonance Imaging

2.6.3.4 Stereotactic Mammography

2.6.3.5 Ultrasound-Guided Biopsy

Exhibit 2-1: Characteristics of Cardiovascular Transcatheter Interventions

Exhibit 2-2: Cardiovascular Transcatheter Interventions, Procedure Volumes Forecast, 2004-2009

Exhibit 2-3: Comparison of Framed and Frameless Neurosurgical Stereotactic Systems

Exhibit 2-4: Characteristics of Image-Guided Neurosurgery

Exhibit 2-5: Image-Guided Neurosurgery, Procedure Volumes Forecast, 2004-2009

Exhibit 2-6: Characteristics of Image-Guided Otolaryngological Procedures

Exhibit 2-7: Image-Guided Otolaryngological Surgery, Procedure Volumes Forecast, 2004-2009

Exhibit 2-8: Characteristics of Selected Computer-Assisted Image-Guided Orthopedic Surgical Procedures

Exhibit 2-9: Image-Guided Orthopedic Surgery, Procedure Volumes Forecast, 2004-2009

Exhibit 2-10: Characteristics of Image-Guided Spinal Surgery

Exhibit 2-11: Image-Guided Spinal Surgery, Procedure Volumes Forecast, 2004-2009

Exhibit 2-12: Types and Configurations of Biopsy Needles

Exhibit 2-13: Comparison of Breast Biopsy Techniques

Exhibit 2-14: Breast Biopsy, Procedure Volumes Forecast, 2004-2009

Exhibit 2-15: Liver Biopsy, Procedure Volumes Forecast, 2004-2009

Exhibit 2-16: Prostate Biopsy, Procedure Volumes Forecast, 2004-2009

3. INTERVENTIONAL IMAGING SYSTEMS MARKET

3.1 Technology

3.1.1 X-Ray Imaging Systems

3.1.1.1 X-Ray System Components

3.1.1.2 Cardiac X-Ray Systems

3.1.1.3 Surgical X-Ray Systems

3.1.1.4 Procedure Volumes

3.1.2 Computed Tomography Systems

3.1.2.1 Computed Tomography Angiography

3.1.2.2 Electron Beam Computed Tomography

3.1.2.3 Multislice Computed Tomography

3.1.2.4 Perfusion Computed Tomography

3.1.2.5 Spiral Computed Tomography

3.1.2.6 Interventional and Surgical Applications

3.1.2.7 Procedure Volumes

3.1.3 Magnetic Resonance Imaging Systems

3.1.3.1 Magnetic Resonance Angiography

3.1.3.1.1 Contrast-Enhanced Magnetic Resonance Angiography

3.1.3.1.2 Phase-Contrast Magnetic Resonance Angiography

3.1.3.1.3 Time-of-Flight Magnetic Resonance Angiography

3.1.3.2 Functional Magnetic Resonance Imaging

3.1.3.3 Proton Magnetic Resonance Spectroscopy

3.1.3.4 Interventional Applications

3.1.3.5 Procedure Volumes

3.1.4 Nuclear Medicine Imaging Systems

3.1.4.1 Gamma Camera Imaging

3.1.4.2 Positron Emission Tomography Imaging

3.1.4.3 Radioimmunoscintigraphy

3.1.4.4 Positron Emission Tomography/Computed Tomography

3.1.4.5 Interventional and Surgical Applications

3.1.4.6 Procedure Volumes

3.1.5 Ultrasound Imaging Systems

3.1.5.1 Echocardiography

3.1.5.1.1 Tissue Harmonic Imaging

3.1.5.2 Doppler Imaging

3.1.5.3 Duplex Ultrasonography

3.1.5.4 Three-Dimensional Ultrasound

3.1.5.5 Contrast-Enhanced Ultrasound

3.1.5.6 Intravascular Ultrasound

3.1.5.7 Interventional and Surgical Applications

3.1.5.8 Procedure Volumes

3.2 Markets for Interventional and Surgical Imaging Systems

3.2.1 X-Ray Imaging Systems

3.2.1.1 Products

3.2.1.2 Market Analysis

3.2.1.3 Competitive Analysis

3.2.2 Computed Tomography Systems

3.2.2.1 Products

3.2.2.2 Market Analysis

3.2.2.3 Competitive Analysis

3.2.3 Magnetic Resonance Imaging Systems

3.2.3.1 Products

3.2.3.2 Market Analysis

3.2.3.3 Competitive Analysis

3.2.4 Nuclear Medicine Imaging Systems

3.2.4.1 Products

3.2.4.2 Market Analysis

3.2.4.3 Competitive Analysis

3.2.5 Ultrasound Imaging Systems

3.2.5.1 Products

3.2.5.2 Market Analysis

3.2.5.3 Competitive Analysis

Exhibit 3-1: Selected Interventional and Surgical Applications of X-Ray Imaging

Exhibit 3-2: Interventional and Surgical Fluoroscopy, Procedure Volumes Forecast, 2004-2009

Exhibit 3-3: Selected Interventional Applications of Computed Tomography

Exhibit 3-4: Interventional and Surgical Computed Tomography, Procedure Volumes Forecast, 2004-2009

Exhibit 3-5: Selected Interventional Applications of Magnetic Resonance Imaging

Exhibit 3-6: Interventional and Surgical Magnetic Resonance Imaging, Procedure Volumes Forecast, 2004-2009

Exhibit 3-7: Selected Interventional and Surgical Applications of Nuclear Medicine Imaging

Exhibit 3-8: Interventional and Surgical Nuclear Medicine Imaging, Procedure Volumes Forecast, 2004-2009

Exhibit 3-9: Selected Interventional and Surgical Applications of Ultrasound Imaging

Exhibit 3-10: Interventional and Surgical Ultrasound, Procedure Volumes Forecast, 2004-2009

Exhibit 3-11: Interventional and Surgical Imaging, Procedure Volumes Forecast, 2004-2009

Exhibit 3-12: Interventional and Surgical Imaging Systems, Market Forecast, 2004-2009

Exhibit 3-13: 2005, Selected Cardiac and Surgical X-Ray Systems

Exhibit 3-14: Interventional and Surgical X-Ray Systems, Market Forecast, 2004-2009

Exhibit 3-15: 2004, Conventional X-Ray Equipment Market, Share by Supplier

Exhibit 3-16: 2005, Selected Computed Tomography Systems

Exhibit 3-17: Interventional and Surgical Computed Tomography Systems, Market Forecast, 2004-2009

Exhibit 3-18: 2004, Computed Tomography Systems, Share by Supplier

Exhibit 3-19: 2005, Selected Magnetic Resonance Imaging Systems

Exhibit 3-20: Interventional and Surgical Magnetic Resonance Imaging Systems, Market Forecast, 2004-2009

Exhibit 3-21: 2004, Magnetic Resonance Imaging Systems Market, Share by Supplier

Exhibit 3-22: 2005, Selected Nuclear Medicine Imaging Systems

Exhibit 3-23: Interventional and Surgical Nuclear Medicine Imaging Systems, Market Forecast, 2004-2009

Exhibit 3-24: 2004, Nuclear Medicine Imaging Systems, Share by Supplier

Exhibit 3-25: 2005, Selected Noninvasive and Intravascular Ultrasound Systems

Exhibit 3-26: Interventional and Surgical Ultrasound Systems, Market Forecast, 2004-2009

Exhibit 3-27: 2004, Noninvasive Ultrasound Systems Market, Share by Supplier

Exhibit 3-28: 2004, Intravascular Ultrasound Systems Market, Share by Supplier

4. SURGICAL NAVIGATION SYSTEMS

4.1 Intraoperative Navigation Overview

4.1.1 Registration Methods and Techniques

4.1.2 Intraoperative Tracking Devices

4.1.3 Interfaces

4.1.4 Image-Guided Surgical Instruments

4.1.5 Supporting Data Management Infrastructure

4.1.6 Navigation Technology Trends

4.1.6.1 Robotic Surgery

4.1.6.1.1 Products

4.1.6.1.1.1 Intuitive Surgical

4.1.6.1.1.2 MD Robotics/MacDonald Dettwiler and Associates

4.1.6.1.1.3 Richard Wolf Medical Instruments/Richard Wolf

4.1.6.1.1.4 University of Washington BioRobotics Laboratory

4.1.6.1.1.5 Other Companies

4.1.6.2 Virtual Reality

4.1.6.3 Augmented Reality

4.1.6.3.1 BrainLAB

4.1.6.3.2 Microvision

4.1.6.3.3 Viking Systems

4.1.6.4 Intraoperative Deformable Tissue Registration

4.2 Surgical Navigation Systems Market

4.2.1 Products

4.2.1.1 Aesculap/B. Braun Melsungen

4.2.1.2 Biomet

4.2.1.3 BrainLAB

4.2.1.4 Center for Medical Robotics and Computer Assisted Surgery

4.2.1.5 DePuy Orthopaedics/Johnson&Johnson

4.2.1.6 GE Healthcare/General Electric

4.2.1.7 Kinamed

4.2.1.8 Mayfield Clinic

4.2.1.9 Medtronic Navigation/Medtronic

4.2.1.10 ORTHOsoft

4.2.1.11 PLUS Orthopedics USA/PLUS Orthopedics

4.2.1.12 Praxim medivision

4.2.1.13 Radionics/Tyco International

4.2.1.14 Smith & Nephew Orthopaedics/Smith & Nephew

4.2.1.15 Stryker

4.2.1.16 Z-KAT

4.2.2 Market Analysis

4.2.3 Competitive Analysis

Exhibit 4-1: Advantages and Disadvantages of Extrinsic and Intrinsic Image Registration Techniques

Exhibit 4-2: Comparison of Selected Intraoperative Tracking Systems

Exhibit 4-3: Current and Emerging Applications of Robotic-Assisted Surgery

Exhibit 4-4: Advantages and Disadvantages of Robotic-Assisted Surgery Compared to Conventional Surgery

Exhibit 4-5: 2005, Selected Current and Emerging Augmented Reality Visualization Systems

Exhibit 4-6: Advantages and Disadvantages of Laser-Based Soft Tissue Registration Tools

Exhibit 4-7: 2005, Selected Surgical Navigation Systems

Exhibit 4-8: Surgical Navigation Systems, Market Forecast, 2004-2009

Exhibit 4-9: 2004, Surgical Navigation Systems Market, Share by Supplier

5. COMPANY PROFILES

5.1 Biomet, Inc.

5.2 BrainLAB, Inc.

5.3 DePuy, Inc./Johnson & Johnson

5.4 GE Healthcare, Inc./General Electric Company

5.5 Hitachi Medical Systems America, Inc./Hitachi LTD

5.6 Medtronic, Inc.

5.7 Philips Medical Systems, Inc./Royal Philips Electronics NV

5.8 Praxim medivision SA

5.9 Radionics, Inc./Tyco International LTD

5.10 Siemens Medical Solutions, Inc./Siemens AG

5.11 Smith & Nephew PLC

5.12 Stryker Corporation

5.13 Toshiba America Medical Systems, Inc./Toshiba Corporation

5.14 Zimmer Holdings, Inc.

5.15 Z-KAT, Inc.

Biomet, Inc.
BrainLAB, Inc.
DePuy, Inc./Johnson & Johnson
GE Healthcare, Inc./General Electric Company
Hitachi Medical Systems America, Inc./Hitachi LTD
Medtronic, Inc.
Philips Medical Systems, Inc./Royal Philips Electronics NV
Praxim medivision SA
Radionics, Inc./Tyco International LTD
Siemens Medical Solutions, Inc./Siemens AG
Smith & Nephew PLC
Stryker Corporation
Toshiba America Medical Systems, Inc./Toshiba Corporation
Zimmer Holdings, Inc.
Z-KAT, Inc.
3D Digital Corporation
Aesculap, Inc.
Agilent Technologies, Inc.
ALOKA Company LTD
Armstrong Healthcare LTD
Aurora Imaging Technology, Inc.
C. R. Bard, Inc.
Biomet, Inc.
Biomet Orthopedics, Inc.
Biosound Esaote, Inc.
Boston Scientific Corporation
BrainLAB, Inc.
Bruker BioSpin, Inc.
Care Wise Medical Products Corporation
Center for Medical Robotics and Computer Assisted Surgery
Cleveland Clinic
COMPASS International, Inc.
Cook Group, Inc.
CryoVascular Systems, Inc.
DePuy Orthopaedics, Inc.
DePuy Spine, Inc.
Digirad Corporation
Dilon Technologies LLC
Elekta AB
Ethicon Endo-Surgery, Inc.
E-Z-EM, Inc.
Fischer Imaging, Inc.
Fonar Corporation
Fukuda Denshi Company LTD
Gamma Medica, Inc.
GE Healthcare, Inc.
Johann Wolfgang Goethe University
Hitachi Medical Systems America, Inc.
Hologic, Inc.
Integra LifeSciences Corporation
Integrated Surgical Systems, Inc.
IntraMedical Imaging LLC
Intuitive Surgical, Inc.
IS2 Medical Systems, Inc.
iVOW, Inc.
Johnson & Johnson
Kinamed, Inc.
Manan Medical Products, Inc.
Mayfield Clinic
Mayo Clinic
MD Robotics LTD
Medical Device Technologies, Inc.
Medison America, Inc.
Medtronic, Inc.
Medtronic Navigation, Inc.
Medtronic Sofamor Danek, Inc.
Medtronic Xomed, Inc.
MicroDexterity Systems, Inc.
Microsoft Corporation
Microvision, Inc.
Millennium Technology, Inc.
NeedleTech Products, Inc.
Neoprobe Corporation
Neothermia Corporation
Northern Digital International, Inc.
Odin Medical Technologies LTD
ORTHOsoft Holdings, Inc.
Philips Medical Systems North America
PLUS Orthopedics USA, Inc.
Positron Corporation
Praxim medivision SA
Radionics, Inc.
Ranfac Corporation
Reichert, Inc.
Sanarus Medical, Inc.
Schaerer Mayfield USA, Inc.
Seaman Family MR Research Centre
Shadyside Hospital
Shimadzu Medical Systems, Inc.
Siemens Medical Solutions USA, Inc.
Smith & Nephew, Inc.
Smith and Nephew Orthopaedics
SonoSite, Inc.
Stryker Corporation
Stryker Leibinger GmbH & Company KG
Stryker Leibinger Micro Implants
Suros Surgical Systems, Inc.
Swissray International, Inc.
Toshiba America Medical Systems, Inc.
Tyco Healthcare Group, Inc.
Tyco International LTD
United States Surgical
University of Washington BioRobotics Laboratory
Vanderbilt University Biomedical Engineering
Viking Systems, Inc.
Volcano Therapeutics, Inc.
Wallace-Kettering Neuroscience Institute
Washington University School of Medicine
Richard Wolf Medical Instruments Corporation
Carl Zeiss AG

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