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AorTech International plc
Arbor Surgical Technologies, Inc
ATS Medical, Inc
CryoLife, Inc
Edwards Lifesciences Corporation
Medtronic, Inc
On-X Life Technologies
Sorin Group
St. Jude Medical, Inc
EXECUTIVE SUMMARY
Overview of Heart Valve Disease
Procedure Trends
Technology Trends
Product Markets
Prosthetic Valves
Surgical Repair Products
Suppliers
Summary Exhibit 1: Prevalence of Major Heart Valve Diseases, 2008-2015
Summary Exhibit 2: Surgical Valve Procedures by Type and Position, 2008-2015
Summary Exhibit 3: Surgical Valve Products, Market Forecast, 2008-2015
Summary Exhibit 4: Prosthetic Valve Products, Market Forecast, 2008-2015
Summary Exhibit 5: Surgical Valve Repair Products, Market Forecast, 2008-2015
Summary Exhibit 6: Leading Suppliers of Surgical Heart Valve Products, 2008
1.0 OVERVIEW OF HEART VALVE DISEASE
1.1 Valve Types and Function
1.2 Role of Valves in Cardiac Cycle
1.3 Etiology of Heart Valve Disease
1.3.1 Rheumatic Heart Disease
1.3.2 Degenerative Valve Disorders
1.3.3 Functional Valve Disorders
1.3.4 Congenital Valve Disorders
1.3.4.1 Complex Congenital Defects
1.3.4.2 Bicuspid Aortic Valve Disease
1.3.5 Bacterial Endocarditis
1.4 Diagnosis of Heart Valve Disease
1.4.1 Auscultation
1.4.2 Electrocardiography
1.4.3 Chest X-rays
1.4.4 Echocardiography
1.4.5 Coronary Angiography
1.4.6 Other Diagnostic Methods
1.5 Treatment of Heart Valve Disease
1.5.1 Medical Management
1.5.2 Surgical Intervention
1.5.3 Transcatheter Valve Implantation and Repair
1.6 Mortality
1.7 Epidemiology of Valve Disease
1.8 Valve Disease by Position
1.8.1 Aortic Valve Disease
1.8.1.1 Aortic Stenosis
1.8.1.1.1 Severity Grading
1.8.1.1.2 Prevalence
1.8.1.1.3 Severe Aortic Stenosis
1.8.1.2 Aortic Valve Regurgitation
1.8.1.2.1 Prevalence
1.8.1.2.2 Treatment
1.8.2 Acquired Mitral Valve Disease
1.8.2.1 Mitral Valve Stenosis
1.8.2.2 Mitral Valve Prolapse
1.8.2.3 Mitral Valve Regurgitation
1.8.2.3.1 Etiologies
1.8.2.3.2 Severity Grading
1.8.2.3.3 Prevalence
1.8.2.3.4 Treatment
1.8.3 Tricuspid Valve Disease
1.8.4 Pulmonary Valve Disease
1.9 Guidelines for Management of Valvular Disease
1.9.1 Aortic Valve Disease
1.9.1.1 Stenosis Replacement
1.9.1.2 Regurgitation
1.9.2 Mitral Valve Disease
1.9.2.1 Mitral Stenosis
1.9.2.2 Mitral Regurgitation
1.9.3 Acute Infective Endocarditis
Exhibit 1-1: The Four Heart Valves
Exhibit 1-2: Etiology of Valvular Disease
Exhibit 1-3: Selected Congenital Heart Defects
Exhibit 1-4: Major Techniques Used to Diagnose Heart Valve Disease
Exhibit 1-5: Information Obtained with Diagnostic Approaches to Valvular Disease
Exhibit 1-6: Treatment Options for Heart Valve Disease
Exhibit 1-7: Use of Drug Therapy in Treatment of Valvular Disease
Exhibit 1-8: Trends in Valve Surgery by Anatomy, 2000-2008
Exhibit 1-9: Mitral and Aortic Surgery Survival Rates
Exhibit 1-10: Overview of Major Epidemiological Studies of Heart Valve Disease
Exhibit 1-11: Selected Findings of Euro Heart Survey on Valvular Heart Disease
Exhibit 1-12: Overview of Aortic Valve Diseases
Exhibit 1-13: Grading of Severity of Aortic Stenosis
Exhibit 1-14: Reported Prevalence of Moderate to Severe Aortic Stenosis
Exhibit 1-15: Severe Aortic Stenosis, Patient Forecast, 2008-2015
Exhibit 1-16: Reported Prevalence of Moderate to Severe Aortic Regurgitation
Exhibit 1-17: Moderate-Severe Aortic Regurgitation, Patient Forecast, 2008-2015
Exhibit 1-18: Comparison of Major Mitral Valve Diseases
Exhibit 1-19: Mitral Regurgitation Etiologies
Exhibit 1-20: Grading of Severity of Mitral Regurgitation
Exhibit 1-21: Reported Prevalence of Moderate to Severe Mitral Regurgitation
Exhibit 1-22: Moderate-Severe Mitral Regurgitation, Patient Forecast, 2008-2015
Exhibit 1-23: Overview of Tricuspid and Pulmonary Valve Diseases
Exhibit 1-24: ACC/AHA Guidelines for Management of Aortic Valve Disease
Exhibit 1-25: ACC/AHA Guidelines for Surgical Management of
2.0 SURGICAL VALVE REPLACEMENT
2.1 Replacement Procedure
2.1.1 Traditional Median Sternotomy Approach
2.1.2 Minimally Invasive Approaches
2.1.2.1 Approaches
2.1.2.2 Advantages
2.1.2.3 Limitations
2.1.3 Enabling/Facilitating Technologies for MI Valve Surgery
2.1.3.1 Robotic Surgery
2.1.3.1.1 Cardiorobotics
2.1.3.1.2 Endocontrol Medical
2.1.3.1.3 Intuitive Surgical
2.1.3.2 Adjunctive Cardiac Surgery Technologies
2.1.3.2.1 Cardio Life Research
2.1.3.2.2 Edwards Lifesciences ENDOAVR System
2.1.3.2.3 NovoSci Ready System
2.1.4 Conclusions Regarding MI Valve Surgery
2.2 Valve Prostheses
2.2.1 Mechanical Valves
2.2.1.1 Designs
2.2.1.2 Materials
2.2.1.3 Advantages
2.2.1.4 Limitations
2.2.2 Xenograft Tissue Valves
2.2.2.1 Tissue Sources
2.2.2.2 Stented versus Stentless
2.2.2.3 Advantages
2.2.2.4 Limitations
2.2.3 Allograft Valves
2.3 Traditional Prosthetic Heart Valve Products
2.3.1 Mechanical Heart Valves
2.3.1.1 ATS Medical
2.3.1.2 CarboMedics (Sorin Group)
2.3.1.3 Medtronic
2.3.1.4 On-X Life Technologies
2.3.1.5 St. Jude Medical
2.3.2 Tissue Heart Valves
2.3.2.1 Edwards Lifesciences
2.3.2.2 Medtronic
2.3.2.3 St. Jude Medical
2.3.2.4 Shelhigh
2.3.2.5 Sorin Group
2.3.3 Allograft Valves
2.3.3.1 Cryopreservation
2.3.3.2 Sterilization and Decellularization
2.3.3.3 Suppliers
2.4 Emerging Prostheses and Approaches
2.4.1 Autologous Tissue Valves
2.4.1.1 CardioMend
2.4.1.2 International Heart Institute
2.4.1.3 Other Programs
2.4.2 New Tissue Valve Designs
2.4.2.1 Arbor Surgical Technologies
2.4.2.2 ATS Medical
2.4.2.3 Shelhigh
2.4.2.4 Sorin
2.4.2.5 ValveXchange
2.4.3 Synthetic Heart Valves
2.4.3.1 AorTech International
2.4.3.2 Innovia LLC
2.4.4 Tissue-Engineered Valves
2.4.4.1 Process and Components
2.4.4.2 Programs
2.4.5.3 Challenges to Commercial Realization
2.4.4.4 Prospects
2.4.5 Valve Suturing and Implantation Technologies
2.4.5.1 ANPA Medical
2.4.5.2 Arbor Surgical Technologies
2.4.5.3 Medtronic
2.4.5.4 Teleflex Medical
2.4.6 Aortic Valve Bypass
2.4.6.1 Clinical Experience
2.4.6.2 Cardious
2.4.6.3 Correx
2.4.7 Transapical Delivery of Percutaneous Valve Technologies
2.4.8 Valve Resection Devices
2.4.8.1 University of Kiel
2.4.8.2 West German Heart Center Essen
2.5 Surgical Valve Replacements
2.5.1 Aortic Valve Replacements
2.5.2 Mitral Valve Replacements
2.5.3 Tricuspid and Pulmonary Replacements
2.6 Prosthetic Valve Consumption
2.7 Market Analysis
2.7.1 Mechanical Valves
2.7.2 Xenograft Valves
Exhibit 2-1: Comparison of Surgical Approaches for Valve Replacement
Exhibit 2-2: Advantages of Minimally Invasive Valve Replacement
Exhibit 2-3: Drawbacks of Minimally Invasive Valve Replacement
Exhibit 2-4: Selected Enabling Technologies for MI Valve Surgery, 2009
Exhibit 2-5: Selected Robotic Technologies with Application to Valve Surgery, 2009
Exhibit 2-6: Selected Adjunctive Cardiac Surgical Technologies with Application for Heart Valve Surgery, 2009
Exhibit 2-7: Design Criteria for Ideal Prosthetic Heart Valve
Exhibit 2-8: Comparison of Mechanical, Tissue and Allograft Heart Valves
Exhibit 2-9: Mechanical Valve Designs
Exhibit 2-10: Prosthetic Tissue Valve Materials and Configurations
Exhibit 2-11: Selected Mechanical Heart Valves, 2009
Exhibit 2-12: Selected Xenograft Tissue Valves, 2009
Exhibit 2-13: Selected Emerging Surgical Valve Technologies, 2009
Exhibit 2-14: Selected Valve Technologies Facilitating MI Implantation, 2009
Exhibit 2-15: Arbor Surgical Technologies’ Trilogy Modular Pericardial Valve
Exhibit 2-16: Comparison of Explanted Trilogy and Perimount Valves
Exhibit 2-17: ATS Medical 3F Therapeutic Heart Valves
Exhibit 2-18: Shelhigh Injectable Stented Pulmonic Valve & Delivery Trocar
Exhibit 2-19: Sorin Perceval S Sutureless Aortic Valve
Exhibit 2-20: ValveXchange VXi Technology
Exhibit 2-21: Selected Synthetic Valve Technologies, 2009
Exhibit 2-22: Tissue Engineering Process
Exhibit 2-23: Selected Heart Valve Tissue Engineering Programs, 2009
Exhibit 2-24: Challenges to Commercialization of Tissue Engineering Products
Exhibit 2-25: Selected Valve Suturing and Advanced Implantation Technologies, 2009
Exhibit 2-26: Cinch Advanced Implantation System versus Standard Holder
Exhibit 2-27: Teleflex Medical Valve Suturing Technologies
Exhibit 2-28: Cardious’ AvA Aortic Valve Bypass Graft System
Exhibit 2-29: Correx LV Connector and Applicator
Exhibit 2-30: Transapical Delivery of Percutaneous Heart Valve
Exhibit 2-31: Selected Transapical Valve Technologies, 2009
Exhibit 2-32: Overview of Valve Resection Development Programs, 2009
Exhibit 2-33: Quaden & Lutter Endoscopic Valve Resection Prototype
Exhibit 2-34: W.German Heart Center Essen, Rotational Valve Resection Prototype
Exhibit 2-35: Surgical Valve Replacements by Position, 2008-2015
Exhibit 2-36: Aortic Valve Replacements, Procedure Forecast, 2008-2015
Exhibit 2-37: Mitral Valve Replacements, Procedure Forecast, 2008-2015
Exhibit 2-38: Non-Specialty Prosthetic Valves, Consumption by Type, 2008-2015
Exhibit 2-39: Prosthetic Valves, Consumption by Type and Position, 2008-2015
Exhibit 2-40: Non-Specialty Prosthetic Valves, Sales Forecast, 2008-2015
Exhibit 2-41: Mechanical Valves, Market Forecast, 2008-2015
Exhibit 2-42: Mechanical Valves, Supplier Shares, 2008
Exhibit 2-43: Xenograft Valves, Market Forecast, 2008-2015
Exhibit 2-44: Xenograft Valves, Supplier Shares, 2008
3.0 SURGICAL VALVE REPAIR
3.1 Techniques
3.2 Operative Approaches.
3.2.1 Traditional Open Heart Surgery
3.2.2 Direct Vision Minimal Access Heart Valve Repair
3.2.3 Video-Assisted Endoscopic Valve Repair
3.2.4 Robotically-Assisted Mitral Valve Repair
3.2.5 Beating Heart Valve Repair
3.2.6 Aortic Valve Sparing Surgery
3.3 Valve Repair Technologies
3.3.1 Annuloplasty Rings
3.3.1.1 Designs
3.3.1.2 Products
3.3.1.2.1 ATS Medical
3.3.1.2.2 Edwards Lifesciences
3.3.1.2.3 Getinge AB
3.3.1.2.4 Medtronic
3.3.1.2.5 Sorin/CarboMedics
3.3.1.2.6 St. Jude Medical
3.3.1.2.7 Shelhigh Inc
3.3.2 Artificial Chordae
3.3.3 Emerging Technologies and Approaches
3.3.3.1 Babic Device
3.3.3.2 Bioring
3.3.3.3 CoroNeo
3.3.3.4 CUBE srl
3.3.3.5 Edwards/Myocor
3.3.3.6 Mardil
3.3.3.7 MiCardia
3.3.3.8 MitralSolutions
3.3.3.9 NeoChord
3.3.3.10 TransCardiac Technologies
3.4 Procedure Forecast by Position
3.5 Market Analysis
3.5.1 Annuloplasty Rings
3.5.2 Other Repair Products
Exhibit 3-1: Heart Valve Surgical Repair Techniques
Exhibit 3-2: Current and Emerging Surgical Approaches for Valve Repair
Exhibit 3-3: Design Characteristics of Annuloplasty Rings
Exhibit 3-4: Selected Annuloplasty Rings, 2009
Exhibit 3-5: Gore-Tex Artificial Chordae
Exhibit 3-6: Selected Emerging Valve Repair Technologies, 2009
Exhibit 3-7: Babic Chordal Replacement Technique and Devices
Exhibit 3-8: Kalangos-Bioring
Exhibit 3-9: CoroNeo Extra-Aortic Ring
Exhibit 3-10: CUBE srl Fully Flexible Annuloplasty Ring
Exhibit 3-11: Myocor Coapsys System
Exhibit 3-12: Mardil BACE Device
Exhibit 3-13: MiCardia Dynamic Annuloplasty Platform
Exhibit 3-14: NeoChord Technology and Approach
Exhibit 3-15: TransCardiac Therapeutics’ MitraFlex System
Exhibit 3-16: Surgical Valve Repairs by Position, Procedure Forecast, 2008-2015
Exhibit 3-17: Surgical Valve Repair Products, Market Forecast, 2008-2015
Exhibit 3-18: Annuloplasty Rings and Accessories, Market Forecast, 2008-2015
Exhibit 3-19: Annuloplasty Rings and Accessories, Supplier Shares, 2008
4.0 SPECIALTY VALVE PRODUCTS
4.1 Clinical Applications
4.1.1 Rastelli, Lecompte and Nikaidoh Procedures
4.1.2 Ross Procedure
4.1.2.1 Approaches
4.1.2.2 Advantages and Limitations
4.1.2.3 Clinical Experience
4.1.2.4 Homograft Alternatives
4.1.2.5 International Ross Registry
4.1.3 Ross II Procedure
4.1.4 Thoracic Aortic Aneurysm with Valve Involvement
4.1.5 Aortic Endocarditis
4.1.6 Bentall Procedure
4.2 Products and Suppliers
4.2.1 ATS Medical
4.2.2 CarboMedics
4.2.3 CryoLife
4.2.4 Edwards Lifesciences
4.2.5 LifeNet
4.2.6 Medtronic
4.2.7 Musculoskeletal Transplant Foundation
4.2.8 Shelhigh
4.2.9 St. Jude Medical
4.3 Emerging Products
4.3.1 Shelhigh
4.3.2 Transapical Approach
4.3.3 Transventricular Approach
4.4 Procedure Forecast
4.5 Market Analysis
Exhibit 4-1: Major Applications for Specialty Valve Products
Exhibit 4-2: Normal Heart and Rastelli Repaired Heart
Exhibit 4-3: Overview of Ross Procedure
Exhibit 4-4: Characteristics of Ross Procedure
Exhibit 4-5: Characteristics of Ross Procedure Patients, 1986-2004
Exhibit 4-6: Major Aortic Components and Selected Aneurysms
Exhibit 4-7: Button Bentall Procedure
Exhibit 4-8: Selected Specialty Valve Products, 2008
Exhibit 4-9: Comparative Literature of Homograft vs Contegra Valved Conduit
Exhibit 4-10: Shelhigh Injectable Stented Pulmonic Valve & Delivery Trocar
Exhibit 4-11: Custom TPV Implant for Transapical Delivery
Exhibit 4-12: Custom Valved Stent for Transventricular Pulmonary Implantation
Exhibit 4-13: Specialty Valve Procedures, Forecast, 2008-2015
Exhibit 4-14: Specialty Valve Products, Market Forecast, 2008-2015
Exhibit 4-15: Specialty Valve Products, Supplier Shares, 2008
5.0 COMPANY PROFILES
5.1 AorTech International plc
5.2 ATS Medical, Inc
5.3 Arbor Surgical Technologies, Inc
5.4 CryoLife, Inc
5.5 Edwards Lifesciences Corporation
5.6 Medtronic, Inc
5.7 On-X Life Technologies
5.8 St. Jude Medical, Inc
5.9 Sorin Group