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U.S. Opportunities in Surgical Coronary Revascularization

Published January 2006 | 506 Pages | 170 Exhibits | Forecasts Through 2010


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Companies Covered

Baxter International, Inc

Cardica, Inc

Chase Medical, Inc

CryoLife, Inc

Edwards Lifesciences Corporation

Endoscopic Technologies, Inc

Getinge AG

Guidant Corporation (Boston Scientific)

Intuitive Surgical, Inc

Johnson & Johnson

Medtronic, Inc

Pall Corporation

Sorin Group

Terumo Corporation

Table of Contents


Procedure Trends

Total Revascularization Products Market

Traditional Cardiopulmonary Bypass Products

Minimally Invasive Cardiac Surgery Technologies

Beating Heart Surgery Products

Anastomosis Devices

Minimally Invasive Vessel Harvesting

Other Surgical Coronary Revascularization Products

Transmyocardial Revascularization

Cardiopulmonary Bypass Surgical Sealants

Adjunctive Technologies

Product Suppliers


Summary Exhibit 1: Coronary Revascularization, Procedures by Type, 2004-2010

Summary Exhibit 2: Surgical Coronary Revascularization Products, Market Forecast, 2004-2010

Summary Exhibit 3: Cardiopulmonary Bypass Products, Market Forecast, 2004-2010

Summary Exhibit 4: Minimally Invasive Cardiac Surgery Technologies, Market Forecast, 2004-2010

Summary Exhibit 5: Other Surgical Coronary Revascularization Products, Market Forecast, 2004-2010

Summary Exhibit 6: Cardiopulmonary Bypass Surgical Sealants, Market Forecast, 2004-2010

Summary Exhibit 7: Adjunctive CABG Surgery Technologies, Market Forecast, 2004-2010

Summary Exhibit 8: Leading Suppliers of Surgical Coronary Revascularization Products, 2005



1.1 Components and Function

1.1.1 Heart

1.1.2 Cardiac Cycle

1.1.3 Blood Vessels

1.2 Disorders of Heart and Circulation

1.2.1 Hypertension

1.2.2 Coronary Heart Disease

1.2.3 Congestive Heart Failure

1.2.4 Cardiac Arrhythmias

1.2.5 Stroke

1.2.6 Rheumatic Heart Disease

1.2.7 Acquired Valve Disorders

1.2.8 Congenital Heart Defects

1.3 Cardiovascular Disease Diagnosis

1.3.1 Non-Imaging Techniques

1.3.2 Imaging Techniques Radiographic Imaging Echocardiography Radionuclide Scanning Magnetic Resonance Imaging Coronary Angiography Intravascular Ultrasound Intracoronary Angioscopy

1.3.3 Emerging Diagnostic Modalities In Vitro Cardiac Markers Predictor Tests Monoclonal Antibody-Based Imaging of Thrombosis

1.4 Treatment of Cardiovascular Disease

1.4.1 Medical Management Traditional Medical Management Lipid-Lowering Drugs

1.4.2 Surgical Intervention Coronary Artery Bypass Surgery Valve Surgery and Treatment of Congenital Heart Defects Transmyocardial Revascularization Surgical Management of Atrial Fibrillation

1.4.3 Transcatheter Therapies Percutaneous Transluminal Coronary Angioplasty Coronary Stenting Laser Angioplasty Atherectomy Transcatheter Thrombectomy and Thrombolysis Transcatheter Defect Repair Percutaneous Transmyocardial Revascularization Catheter Ablation of Arrhythmias

1.5 Determinants of CABG Caseload

1.5.1 Anatomy of Major Coronary Artery Systems

1.5.2 Overview of Left Main Disease

1.5.3 Characterization of Left Main Disease Kyriakidis Study Roeters van Lennep Study

1.5.4 NHDS Data on CABG Surgeries

1.5.5 Implications for CABG Surgery Caseload

1.5.6 Trials of Drug-Eluting Stents versus CABG Surgery


Exhibit 1-1: The Heart

Exhibit 1-2: Selected Data on Heart Disease, 2003

Exhibit 1-3: Estimated Costs of Cardiovascular Disease and Stroke, 2006

Exhibit 1-4: Overview of Major Heart and Circulatory Disorders

Exhibit 1-5: Comparison of Left and Right-Sided Heart Failure

Exhibit 1-6: Selected Types of Arrhythmia

Exhibit 1-7: Major Congenital Heart Defects

Exhibit 1-8: Techniques Used for Diagnosing Cardiovascular Disease

Exhibit 1-9: Principal Drugs Used in the Treatment of Cardiovascular Disease, 2006

Exhibit 1-10: Major Surgical Interventions for Cardiovascular Disease, 2006

Exhibit 1-11: Transcatheter Interventions for Cardiovascular Disease, 2006

Exhibit 1-13: Major Coronary Artery Systems

Exhibit 1-14: Comparison of Two Studies Characterizing Coronary Artery Disease

Exhibit 1-15: Kyriakidis: Vessels Involved in Coronary Artery Disease by Sex and Age Group

Exhibit 1-16: Kyriakidis: Significant Coronary Artery Disease by Lesion Site

Exhibit 1-17: Kyriakidis: Single-Vessel Coronary Artery Disease by Site, Sex and Age

Exhibit 1-18: Roeters van Lennep: Vessels Involved in Coronary Artery Disease by Sex

Exhibit 1-19: Roeters van Lennep: Significant Coronary Artery Disease by Lesion Site1-60

Exhibit 1-20: Roeters van Lennep: Single-Vessel Coronary Artery Disease by Lesion Site

Exhibit 1-21: Roeters van Lennep: Use of Revascularization by Vessel Involvement

Exhibit 1-22: Roeters van Lennep: Distribution of CABG Surgery Patients by Vessel Involvement

Exhibit 1-23: NHDS Data: Trend in Bypass Procedures by Type, 1987-2002

Exhibit 1-24: American College of Cardiology (ACC): Indications for CABG Surgery

Exhibit 1-25: CABG Surgery, Procedure Trend, 2004-2010

Exhibit 1-26: Selected Trials of PCI and DES versus CABG Surgery



2.1 Cardiopulmonary Bypass

2.1.1 Extracorporeal Circuit

2.1.2 Complications

2.1.3 Products Blood Pumps Roller Pumps Centrifugal Pumps Oxygenators Design and Function Add On Features Products and Suppliers Accessories Blood Filters Hemoconcentrators Cannulae

2.1.4 Developments in Cardiopulmonary Bypass Reduce Bypass Volume and Blood-Surface Contact CardioVention COBE/Sorin Maquet/Getinge Medtronic Terumo Cardiovascular Reduced Embolic Risk Cardio Medical Solutions Chase Medical Edwards Lifesciences Estech Guidant/Boston Scientific Novare Surgical Systems

2.1.5 New Coatings

2.2 Blood Recovery and Salvage

2.2.1 Cardiotomy Suction

2.2.2 Intraoperative Cell Washing and Autotransfusion Protocol Products and Technology Comparative Performance Product Trends Procedures

2.3 Myocardial Protection

2.3.1 Cardioplegia Circuit

2.3.2 Access for Cardioplegia

2.3.3 Cold versus Warm Cardioplegia

2.3.4 Products and Technology

2.4 Procedure Forecasts

2.4.1 Coronary Artery Bypass Graft Surgery

2.4.2 Valve Procedures

2.4.3 Other Procedures

2.5 Product Markets and Supplier Shares

2.5.1 Blood Pumps

2.5.2 Cardiopulmonary Bypass Circuit Disposables

2.5.3 Autotransfusion Kits

2.5.4 Emerging Bypass Disposables

2.5.5 Supplier Shares


Exhibit 2-1: Product Requirements for Open Heart Surgery Supported by Cardiopulmonary Bypass

Exhibit 2-2: Schematic of Cardiopulmonary Bypass Circuit

Exhibit 2-3: Potential Complications Associated with Cardiopulmonary Bypass

Exhibit 2-4: Disposables Used During On-Pump Open Heart Surgery

Exhibit 2-5: Estimated Cost Components of Cardiopulmonary Bypass Circuit

Exhibit 2-6: Comparison of Roller and Centrifugal Pumps

Exhibit 2-7: Selected Heart-Lung Machines, 2006

Exhibit 2-8: Selected Centrifugal Pump Systems, 2006

Exhibit 2-9: Comparison of Soft-Shell and Hard-Shell Venous Reservoirs

Exhibit 2-10: Selected Membrane Oxygenators, 2006

Exhibit 2-11 Selected Filters Employed in Cardiopulmonary Bypass Circuit

Exhibit 2-12: Comparison of Major Approaches Used to Reduce Bypass Complications

Exhibit 2-13: Selected Technologies Reducing Bypass Volume

Exhibit 2-14: CardioVention CORx System

Exhibit 2-15: COBE Synergy Mini-Bypass Circuit

Exhibit 2-16: Maquet MECC System

Exhibit 2-17: Medtronic Portable Bypass System (PBS)

Exhibit 2-18: Medronic Resting Heart Platform

Exhibit 2-19: Terumo Cardiovascular Systems' Mini Perfusion Circuits

Exhibit 2-20: Selected Technologies Reducing Aortic Manipulation

Exhibit 2-21: Cardio Medical Solutions Baladi Inverter

Exhibit 2-22: Chase Medical Triumph Soft Occlusion Aortic Cannula

Exhibit 2-23: Edwards’ EMBOL-X Aortic Filter System

Exhibit 2-24: Estech Remote Access Perfusion Catheter

Exhibit 2-25: Blood Conservation Strategies for Cardiac Surgery

Exhibit 2-26: Selected Current and Emerging Cardiac Surgery Autotransfusion Systems, 2006

Exhibit 2-27: Haemonetics' CardioPAT System

Exhibit 2-28: Global Blood Resources' Hemobag

Exhibit 2-29: Major Indications for Open Heart Surgery

Exhibit 2-30: Trend in CABG Surgery by Approach, Procedure Forecasts, 2004-2010

Exhibit 2-32: Stopped Heart versus Beating Heart CABG Surgery, Procedure Forecast, 2004-2010

Exhibit 2-33: Total Cardiopulmonary Bypass Caseload, Procedure Forecast, 2004-2010

Exhibit 2-34: Cardiopulmonary Bypass Products, Market Forecast, 2004-2010

Exhibit 2-35: Traditional Heart-Lung Machines, Market Forecast, 2004-2010

Exhibit 2-36: Centrifugal Pump Consoles, Market Forecast, 2004-2010

Exhibit 2-37: Cardiopulmonary Bypass Disposables, Market Forecast, 2004-2010

Exhibit 2-38: Cardiac Surgery Autotransfusion Kits, Market Forecast, 2004-2010

Exhibit 2-39: Cardiac Surgery Autotransfusion Kits, Supplier Shares, 2005

Exhibit 2-40: Embolic Protection Devices, Market Forecast, 2004-2010

Exhibit 2-41: Cardiopulmonary Bypass Products, Supplier Shares, 2005



3.1 Beating Heart Techniques

3.1.1 Clinical Indications

3.1.2 Procedure Forecast

3.2 Beating Heart Systems (Stabilizers and Positioners)

3.2.1 Products and Suppliers Beating Heart Surgical Instruments (Vitalcor) Boston Scientific Chase Medical CoroNéo ESTECH Ethicon (CardioVations) MediVas OPCAB Medtronic Teleflex Medical Tokyo Medical and Dental University

3.2.2 Market Analysis

3.3 Anastomosis Assist Devices

3.3.1 Products and Suppliers Boston Scientific (Guidant) Novare Surgical Systems

3.3.2 Market Analysis

3.4 Automated Anastomosis Devices

3.4.1 Design Criteria

3.4.2 Products and Suppliers Cardica PAS-Port Proximal Anastomosis System C-Port Distal Anastomosis System C-Port xA C-Port Flex A iiTech Medtronic U-Clip Spyder Rintek Systems St. Jude Medical

3.4.3 Market Analysis

3.5 Intracoronary Shunts

3.5.1 Design

3.5.2 Application

3.5.3 Advantages and Limitations

3.5.4 Clinical Experience

3.5.5 Products and Suppliers

3.6 Intrasurgical Cardiac Assist

3.7 Minimally Invasive Vessel Harvesting

3.7.1 Graft Sources Radial Artery Grafts Gastroepiploic Artery Grafts Internal Thoracic Artery Grafts Artificial Coronary Grafts

3.7.2 Minimally Invasive Harvesting Techniques Harvesting Technique Advantages, Limitations and Guidelines Products and Suppliers Boston Scientific Datascope Ethicon (CardioVations) Karl Storz Endoscopy SurgRx Teleflex Medical Terumo Cardiovascular Systems Tyco Healthcare Market Analysis


Exhibit 3-1: Minimally Invasive Cardiac Surgery Technologies, 2006

Exhibit 3-2: Comparison of Beating Heart CABG Surgery Techniques

Exhibit 3-3: Benefits and Limitations of OPCAB

Exhibit 3-4: U.S. Beating Heart CABG Procedures, 2004-2010

Exhibit 3-5: Selected Cardiac Stabilizers, Positioners and Retractor Systems, 2006

Exhibit 3-6: Beating Heart Surgical Instruments' Platypus Reusable Stabilizer

Exhibit 3-7: Boston Scientific Beating Heart Products

Exhibit 3-8: Chase Medical TRIPOD Stabilizer System

Exhibit 3-9: CoroNeo Cor-Vasc System

Exhibit 3-10: ESTECH Stabilizer and Positioner Products

Exhibit 3-11: CardioVations Embrace Stabilization System

Exhibit 3-12: Medtronic Beating Heart Surgery Products

Exhibit 3-13: Teleflex Medical Beating Heart Surgery Products

Exhibit 3-14: Tentacles Cardiac Positioner

Exhibit 3-15: U.S. Beating Heart Product Market, 2004-2010

Exhibit 3-16: U.S. Beating Heart Products, Supplier Shares, 2004-2005

Exhibit 3-17: Selected Anastomosis Assist Devices, 2006

Exhibit 3-18: Boston Scientific Heartstring II Proximal Seal System

Exhibit 3-19: Selected Studies of the Heartstring Proximal Seal System

Exhibit 3-20: Novare Surgical Systems Enclose II Anastomosis Assist Device

Exhibit 3-21: Selected Clinical Studies of the Enclose System

Exhibit 3-22: U.S. Coronary Anastomoses, 2004-2010

Exhibit 3-23: U.S. Anastomosis Assist Device Market, 2004-2010

Exhibit 3-24: Anastomosis Assist Devices, Supplier Shares, 2004-2005

Exhibit 3-25: Major Design Approaches for Automated Anastomosis Devices

Exhibit 3-26: Selected Automated Anastomosis Devices, 2006

Exhibit 3-27: Cardica's Automated Anastomosis Devices

Exhibit 3-28: Clinical Results with Cardica's PAS-Port Proximal Anastomosis System

Exhibit 3-29: iiTech's S² Anastomotic System

Exhibit 3-30: Medtronic's U-Clip and SPYDER Devices

Exhibit 3-31: Selected Clinical Studies of the U-Clip Device

Exhibit 3-32: Rintek CABG Instrument

Exhibit 3-33: Deployment of Rintek CABG Instrument

Exhibit 3-34: U.S. Market for Automated Anastomosis Devices, 2004-2010

Exhibit 3-35: Advantages and Limitations of Intracoronary Shunting for Beating Heart CABG Surgery

Exhibit 3-36: Selected Clinical Studies of Intracoronary Shunts

Exhibit 3-37: Selected Intracoronary Shunt Product and Suppliers, 2006

Exhibit 3-38: Comparison of CABG Graft Sources

Exhibit 3-39: Selected Studies of Radial Artery Harvesting

Exhibit 3-40: Selected Studies of GEA Grafting for Revascularization

Exhibit 3-41: Selected Studies of ITA Grafts for Revascularization

Exhibit 3-42: Selected Artificial Coronary Graft Programs, 2006

Exhibit 3-43: Advantages and Limitations of Minimally Invasive Vein Harvesting

Exhibit 3-44: Selected Minimally Invasive Vessel Harvesting Systems, 2006

Exhibit 3-45: Boston Scientific's VasoView EVH Systems

Exhibit 3-46: Datascope's ClearGlide EVH System

Exhibit 3-47: Clinical Use of the Harmonic Scalpel in Minimally Invasive Vessel Harvesting

Exhibit 3-48: Teleflex Medical's SaphLITE/RadLITE System with Genzarm

Exhibit 3-49: Terumo's VirtuoSaph Endoscopic Vein Harvesting System

Exhibit 3-50: Tyco Healthcare's Mini-Harvest and ENDOsaph Systems

Exhibit 3-51: U.S. Market for Minimally Invasive Vessel Harvesting Systems, 2004-2010

Exhibit 3-52: Minimally Invasive Vein Harvesting Systems, Supplier Shares, 2005



4.1 Robotic Systems

4.1.1 Background

4.1.2 Technology Automated Mechanical Assist Devices Telemanipulators Autonomous Robots

4.1.3 Applications in Cardiac Surgery

4.1.4 Regulatory Issues

4.1.5 Reimbursement

4.1.6 Products Armstrong Healthcare Limited EndoAssist PathFinder Enhanced Medical Systems Hansen Medical Intuitive Surgical daVinci Surgical System AESOP MedSys Micro Dexterity Systems

4.1.7 Procedure Trend

4.1.8 Market Analysis

4.2 Advanced Visualization Systems

4.2.1 Technology

4.2.2 Requirements for Success.

4.2.3 Products and Suppliers Estech InnerOptic Technology Medisecur AG Microvision Olympus Optical Company Schoelly Fiberoptik GmbH (Intuitive Surgical) Karl Storz Endoscopy VisionSense Viking Systems VRex

4.2.4 Market Analysis

4.3 Endoscopic Tools

4.3.1 Intuitive Surgical (Endo-ACAB)

4.3.2 Johnson & Johnson CardioVations Products Procedure Heartport Endoscopic CABG Robotically-Assisted TECAB Clinical Experience Hybrid Revascularization

4.3.3 Market Analysis


Exhibit 4-1: Types of Surgical Robots

Exhibit 4-2: Selected Robotic Systems with Potential Application to Cardiac Surgery

Exhibit 4-3: Armstrong Healthcare EndoAssist and PathFinder

Exhibit 4-4: Enhanced Medical Systems' HeartLander System

Exhibit 4-5: Hansen Medical Sensei Robotic Catheter System

Exhibit 4-6: Intuitive Surgical daVinci System

Exhibit 4-7: daVinci Surgical System U.S. Installed Base

Exhibit 4-8: Intuitive Surgical AESOP 3000 System

Exhibit 4-9: MedSys LapMan Robotic Endoscope Positioner

Exhibit 4-10: Robotic-Assisted Beating Heart Cardiac Surgery, U.S. Equipment and Procedure Forecasts, 2004-2010

Exhibit 4-11: Cardiac Robotic Systems, Market Forecast, 2004-2010

Exhibit 4-12: Methods of Achieving Three-Dimensional Endoscopic Visualization

Exhibit 4-13: Selected Advanced Visualization Systems, 2006

Exhibit 4-14: InnerOptic 3D Laparoscope System and Head-Mounted Display

Exhibit 4-15: Viking Systems’ EndoSite 3Di Digital Vision System

Exhibit 4-16: Stand-Alone Advanced Visualization Systems, Market Forecast, 2004-2010

Exhibit 4-17: Suggested Anastomosis Technique for Beating Heart TECAB

Exhibit 4-18: Endoscopic CABG Surgery, Procedure and Market Forecast, 2004-2010



5.1 Surgical Sealant Design Criteria

5.2 Types of Surgical Sealants

5.3 Biological Hemostatic Agents

5.3.1 Fibrin Sealants Mechanism of Action Development History and Impact Clinical Applications Commercial versus Non-Commercial Products Commercial Fibrin Sealant Products Baxter Bioscience (Tisseel) Haemacure Corporation (Hemaseel) Omrix Biopharmaceuticals/Ethicon (Crosseal, Evicel)

5.3.2 Hemostatic Matrices Baxter Bioscience (FloSeal) Ethicon (SurgiFlo) Orthovita/Angiotech Pharmaceuticals

5.3.3 Autologous Platelet Products. Biomet (Gravitational Platelet Separation System) Harvest Technologies ThermoGenesis Vivolution A/S

5.4 Recombinant Surgical Hemostasis Products

5.4.1 Pharming Group NV

5.4.2 ZymoGenetics

5.5 Synthetic Sealants

5.5.1 Angiotech Pharmaceuticals/Baxter

5.5.2 CryoLife

5.5.3 Johnson & Johnson/Closure Medical Corporation

5.5.4 Tissuemed

5.6 Allogenic Products

5.7 Viral Screening and Inactivation of Blood Products

5.7.1 New Risks

5.7.2 Viral Inactivation and Removal Methods

5.8 Market Analysis

5.9 Supplier Shares


Exhibit 5-1: Design Criteria for Ideal Surgical Sealant

Exhibit 5-2: Types of Surgical Sealants

Exhibit 5-3: Selected Biologic Fibrin Sealants, 2006

Exhibit 5-4: Selected Hemostatic Matrices, 2006

Exhibit 5-5: Selected Technologies Producing Autologous Platelet Gels and Fibrin Sealant, 2006

Exhibit 5-6: Selected Recombinant Surgical Hemostasis Programs, 2006

Exhibit 5-7: Selected Synthetic Sealants, 2006

Exhibit 5-8: Current and Emerging Viral Inactivation and Removal Technologies

Exhibit 5-9: Cardiac Surgical Sealants, Market Forecast by Type, 2004-2010

Exhibit 5-10: Cardiopulmonary Bypass Surgical Sealants, Supplier Shares, 2005



6.1 Clinical Background

6.2 TMR Technique

6.3 Clinical Results

6.3.1 Long-Term Results

6.3.2 Adjunctive Use with CABG

6.3.3 Endoscopic and Robotically Assisted TMR

6.3.4 Cardiac Allograft Vasculopathy

6.4 Proposed Mechanisms of Action

6.4.1 Channel-Mediated Perfusion

6.4.2 Angiogenesis

6.4.3 Myocardial Denervation

6.4.4 Placebo Effect

6.5 Products and Suppliers

6.5.1 CardioGenesis Technology Clinical Use PMC

6.5.2 Photomedex Litigation Current Status

6.5.3 PLC Medical Systems Technology Clinical Use Relationship with Edwards Lifesciences

6.6 Reimbursement

6.7 Market Analysis

6.7.1 Procedure Forecast

6.7.2 Market Forecast

6.7.3 Competitive Analysis


Exhibit 6-1: Standard Angina Classification

Exhibit 6-2: Characteristics of "No Option" Angina Patients

Exhibit 6-3: Comparison of TMR and PMC

Exhibit 6-4: TMR Practice Guidelines, Recommendations

Exhibit 6-5: Summary Results of Randomized Clinical Trials for Sole Therapy TMR

Exhibit 6-6: Selected Clinical Studies of Concomitant TMR with CABG

Exhibit 6-7: Transmyocardial Revascularization: Potential Mechanisms of Action

Exhibit 6-8: Overview of Selected Studies Combining TMR with Gene or Cell Therapy

Exhibit 6-9: Selected Transmyocardial Laser Revascularization Programs

Exhibit 6-10: CardioGenesis TMR 2000 Holmium:YAG Laser TMR System

Exhibit 6-11: Cardiogenesis TMR Plus Platform

Exhibit 6-12: PLC Medical Systems' Heart Laser 2 TMR System

Exhibit 6-13: Transmyocardial Revascularization, Procedure Forecast, 2004-2010

Exhibit 6-14: Transmyocardial Revascularization, Market Forecast, 2004-2010

Exhibit 6-15: Transmyocardial Revascularization, Supplier Shares, 2005



7.1 Baxter International, Inc

7.2 Cardica, Inc

7.3 Chase Medical, Inc

7.4 CryoLife, Inc

7.5 Edwards Lifesciences Corporation

7.6 Endoscopic Technologies, Inc

7.7 Getinge AG

7.8 Guidant Corporation (Boston Scientific)

7.9 Intuitive Surgical, Inc

7.10 Johnson & Johnson

7.11 Medtronic, Inc

7.12 Pall Corporation

7.13 Sorin Group

7.14 Terumo Corporation

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