U.S. Opportunities in Transcatheter Heart Valve Technologies

Table of Contents

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