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EXECUTIVE SUMMARY
Transcatheter Aortic Valve Implantation
Transcatheter Mitral Valve Repair
Transcatheter Pulmonary Valve Implantation
Transcatheter Mitral Valve Implantation
Percutaneous Balloon Valvuloplasty
Companies
Edwards Lifesciences
Medtronic
Other Companies
Summary Exhibit 1: Overview of Transcatheter Heart Valve Technologies
Summary Exhibit 2: U.S. Transcatheter Heart Valve Procedures by Type, 2008-2015
Summary Exhibit 3: U.S. Transcatheter Heart Valve Market, Sales by Segment, 2008-2015
Summary Exhibit 4: Projected Rollout of Selected Transcatheter Heart Valve Programs
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 Etiology
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 Aortic Stenosis
1.9.1.2 Aortic 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 Selected 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 1-25: ACC/AHA Guidelines for Management of Aortic Valve Disease
Exhibit 1-25: ACC/AHA Guidelines for Surgical Management of Nonischemic Mitral Regurgitation
2.0 TRANSCATHETER AORTIC VALVE IMPLANTATION
2.1 Patient Selection
2.1 Delivery Approaches
2.2 Clinical Experience
2.3 Products and Suppliers
2.3.1 Advanced Bio Prosthetic Surfaces (Palmaz Scientific)
2.3.2 ATS Medical
2.3.3 Coremove
2.3.4 Direct Flow Medical
2.3.5 Edwards Lifesciences
2.3.6 Endoluminal Technology Research
2.3.7 Hansen Medical (AorTx)
2.3.8 Heart Leaflet Technologies
2.3.9 JenaValve Technology
2.3.10 Medtronic
2.3.10.1 CoreValve
2.3.10.2 Ventor Technologies
2.3.11 Sadra Medical
2.3.12 St. Jude Medical
2.3.13 Sorin
2.3.14 TheraNova
2.3.15 ValveXchange
2.4 Transcatheter Valve Resection
2.4.1 University of Kiel
2.4.2 West German Heart Center Essen
2.5 Procedure Forecast
2.6 Market Analysis
Exhibit 2-1: Overview of Transcatheter Aortic Valve Implantation Approaches
Exhibit 2-2: Overview of TAVI Clinical Experience
Exhibit 2-3: Overview of Transcatheter Aortic Valve Designs
Exhibit 2-4: Transcatheter Aortic Valve Implantation Programs, 2009
Exhibit 2-5: Advanced Bio Prosthetic Surfaces' PercValve System
Exhibit 2-6: The ATS 3f Entrata Aortic Valve System:
Exhibit 2-7: The Coremove Repositionable Valved Stent
Exhibit 2-8: Direct Flow Medical's Aortic Valve Prosthesis
Exhibit 2-9: Edwards Lifesciences' Sapien Valve
Exhibit 2-10: Transapical Delivery of the Sapien Valve
Exhibit 2-11: Endoluminal Technology Research Valve
Exhibit 2-12: The AorTx Self-Expanding Valve
Exhibit 2-13: Heart Leaflet Technologies' TAVR System
Exhibit 2-14: Components of the JenaValve Aortic Valve Replacement System
Exhibit 5-15: Medtronic's CoreValve System
Exhibit 2-16: Medtronic's Embracer Aortic Valve Bioprosthesis
Exhibit 2-17: Sadra Medical's Lotus Valve System
Exhibit 2-18: St. Jude Medical's Self Expanding Transcatheter Aortic Valve System
Exhibit 2-19: Sorin's Perceval Valve
Exhibit 2-20: ValveXchange VXi System
Exhibit 2-21: Overview of Valve Resection Development Programs, 2009
Exhibit 2-22: Quaden & Lutter Endoscopic Valve Resection Prototype
Exhibit 2-23: West German Heart Center Essen, Rotational Valve Resection Prototype
Exhibit 2-24: TAVI Candidates, 2008
Exhibit 2-25: U.S. Transcatheter Aortic Valve Implantation Procedures by Source, 2011-2015
Exhibit 2-26: U.S. Transcatheter Aortic Valve Implantation Procedures by Approach, 2011-2015
Exhibit 2-27: Projected Rollout of Selected TAVI Programs
Exhibit 2-28: U.S. Transcatheter Aortic Valve Implantation Market, 2011-2015
3.0 TRANSCATHETER MITRAL VALVE REPAIR
3.1 Etiology
3.1.1 Degenerative Mitral Valve Regurgitation
3.1.2 Functional Mitral Valve Regurgitation
3.1.3 Other Mitral Valve Regurgitation
3.2 Transcatheter Approaches
3.2.1 Edge-To-Edge Repair
3.2.2 Coronary Sinus Annuloplasty
3.2.3 Mitral Valve Remodeling
3.2.4 Direct Annuloplasty
3.2.5 Chordal Replacement
3.3 Technologies
3.3.1 Ample Medical
3.3.2 Uros Babic M.D.
3.3.3 Cardiac Dimensions
3.3.4 Cardiosolutions
3.3.5 Cordis (Johnson & Johnson)
3.3.6 Nicholas Dang, M.D.
3.3.7 Edwards Lifesciences
3.3.7.1 Mobius
3.3.7.2 MONARC
3.3.7.3 Myocor iCoapsys
3.3.8 Evalve
3.3.9 Guided Delivery Systems
3.3.10 Kardium
3.3.11 Mardil
3.3.12 MiCardia
3.3.13 Mitralign
3.3.14 QuantumCor
3.3.15 ProRhythm
3.3.16 St. Jude Medical
3.3.17 Viacor
3.4 Procedure Caseload by Source and Approach
3.5 Market Analysis
Exhibit 3-1: Mechanisms of Mitral Regurgitation
Exhibit 3-2: Characterization of Major Types of Mitral Regurgitation
Exhibit 3-3: Major Etiologies of Degenerative Mitral Valve Disease
Exhibit 3-4: Comparison of Transcatheter Approaches to Mitral Valve Repair
Exhibit 3-5: Selected Percutaneous Mitral Valve Repair Programs, 2009
Exhibit 3-6: Ample Medical Percutaneous Septal Sinus Shortening (PS³) System
Exhibit 3-7: Babic Chordal Replacement Technique and Devices
Exhibit 3-8: Cardiac Dimensions Carillon Mitral Contour System
Exhibit 3-9: Cardiosolutions' Percu-Pro System
Exhibit 3-10: Cordis' Direct Plication Annuloplasty (DPA) System
Exhibit 3-11: Edwards Lifesciences' MOBIUS Leaflet Repair System
Exhibit 3-12: Edwards Lifesciences MONARC Coronary Annuloplasty System
Exhibit 3-13: Myocor iCoapsys System
Exhibit 3-14: Evalve MitraClip System
Exhibit 3-15: Guided Delivery Systems' AccuCinch
Exhibit 3-16: Mardil BACE Device
Exhibit 3-17: MiCardia Dynamic Annuloplasty Platform
Exhibit 3-18: Mitralign Percutaneous Annuloplasty System
Exhibit 3-19: QuantumCor RF Mitral Annuloplasty Technology
Exhibit 3-20: ProRhythm Ultrasonic Mitral Annulus Reduction Technology
Exhibit 3-21: Viacor Percutaneous Transvenous Mitral Annuloplasty Technology
Exhibit 3-22: Transcatheter Mitral Valve Repair, Procedure Forecast by Source, 2010-2015
Exhibit 3-23: Transcatheter Mitral Valve Repair, Procedure Forecast by Approach, 2010-2015
Exhibit 3-24: Transcatheter Mitral Valve Repair Technologies, Market Forecast, 2010-2015
4.0 OTHER TRANSCATHETER HEART VALVE TECHNOLOGIES
4.1 Transcatheter Pulmonary Valve Implantation
4.1.1 Products and Suppliers
4.1.1.1 Cook Biotech
4.1.1.2 Edwards Lifesciences
4.1.1.3 Medtronic
4.1.1.4 Shelhigh Inc
4.1.1.5 Other TPVI Programs
4.1.1.5.1 Transapical Approach
4.1.1.5.2 Transventricular Approach
4.1.1.5.3 Transfemoral Approach
4.1.1.5.4 Downsizing Device
4.1.2 Procedure Forecast
4.1.3 Market Analysis
4.2 Transcatheter Mitral Valve Implantation
4.2.1 CardiAQ Valve Technologies
4.2.2 Endovalve
4.2.3 Other TMVI Programs
4.2.4 Valve In Valve Approaches
4.2.5 Market Assessment
Exhibit 4-1: Transcatheter Pulmonary Valve Implantation Programs, 2009
Exhibit 4-2: The Cook-SIS Valve
Exhibit 4-3: Medtronic Melody Transcatheter Pulmonary Valve
Exhibit 4-4: Shelhigh Injectable Stented Pulmonic Valve & Delivery Trocar
Exhibit 4-5: Custom TPV Implant for Transapical Delivery
Exhibit 4-6: Custom Valved Stent for Transventricular Pulmonary Implantation
Exhibit 4-7: Downsize Stent for TPVI
Exhibit 4-8: U.S. Transcatheter Pulmonary Valve Implantation Procedures, 2009-2015
Exhibit 4-9: U.S. Transcatheter Pulmonary Valve Implantation Market, 2009-2015
Exhibit 4-10: Selected Transcatheter Mitral Valve Implantation Programs, 2009
Exhibit 4-11: CardiAQ Valve Technologies PMVR
Exhibit 4-12: The Endovalve Mitral Replacement Prosthesis
Exhibit 4-13: Transapical Mitral Valve Replacement System
Exhibit 4-14: Double-Crowned Valved Stent for Transatrial Mitral Replacement
5.0 PERCUTANEOUS BALLOON VALVULOPLASTY
5.1 Clinical Applications
5.2 Procedure
5.3 Single versus Double Balloon Techniques
5.4 Clinical Outcomes
5.5 Products
5.5.1 NuMED
5.5.1.1 Tyshak
5.5.1.2 Z-Med
5.5.1.3 COEfficient
5.5.1.4 Nucleus-X
5.5.1.5 Multi-Track
5.5.2 Toray
5.6 Procedures
5.7 Market Analysis
Exhibit 5-1: AHA/ACC Recommendations for Percutaneous Balloon Valvuloplasty
Exhibit 5-2: Selected Studies Comparing Single and Double Balloon Valvuloplasty
Exhibit 5-3: Selected Studies of PBV for Mitral Stenosis
Exhibit 5-4: Reported Complications in Aortic Valvuloplasty Registries
Exhibit 5-5: A Thirty-Year Experience with Aortic Valve Stenosis
Exhibit 5-6: Selected Percutaneous Balloon Valvuloplasty Catheters, 2009
Exhibit 5-7: Percutaneous Balloon Valvuloplasty, U.S. Procedures, 2008-2015
Exhibit 5-8: Percutaneous Balloon Valvuloplasty, U.S. Market, 2008-2015
Exhibit 5-9: Percutaneous Balloon Valvuloplasty, U.S. Supplier Shares, 2008