U.S. Opportunities in Surgical Heart Valve Technologies

Companies Covered

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

Table of Contents

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