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European Markets for Heart Valve Repair and Replacement Products

Published by: Medtech Insight

Published: Feb. 1, 2008


Table of Contents


EXECUTIVE SUMMARY

i. Types of Heart Valve Disorders

a. Valvular Stenosis

b. Valvular Regurgitation

c. Valve Prolapse

ii. Heart Valve Disorder Treatment Strategies

iii. Heart Valve Repairs and Replacements, Combined Procedure Volumes Forecast

a. Annuloplasty Device Implantations

b. Mechanical Heart Valve Implantations

c. Tissue Valve Implantations

iv. Heart Valve Repair and Replacement Products, Combined Market Forecast

a. Annuloplasty Device Sales

b. Mechanical Heart Valve Sales

c. Tissue Heart Valve Sales

v. Methodology


Exhibit ES-1: Euro Heart Survey on Valvular Heart Disease Patient Population, Native Heart Valve Disorders, by Type

Exhibit ES-2: Europe, Heart Valve Repair and Replacement, Combined Procedure Volumes Forecast, 2003-2013

Exhibit ES-3: Europe, Annuloplasty Device Implantation, Procedure Volumes Forecast, by Country, 2007-2013

Exhibit ES-4: Europe, Mechanical Heart Valve Implantation, Procedure Volumes Forecast, by Country, 2003-2013

Exhibit ES-5: Europe, Tissue Heart Valve Implantations, Procedure Volumes Forecast, by Country, 2003-2013

Exhibit ES-6: Europe, Heart Valve Repair and Replacement Products, Combined Market Forecast, 2003-2013

Exhibit ES-7: Europe, Annuloplasty Devices, Market Forecast, by Country, 2003-2013

Exhibit ES-8: Europe, Mechanical Heart Valves, Market Forecast, by Country, 2003-2013

Exhibit ES-9: Europe, Tissue Heart Valves, Market Forecast, by Country, 2003-2013


1. EUROPEAN HEALTHCARE MARKETS

1.1 The European Union

1.1.1 A Common Currency

1.1.2 Regulatory Policies

1.1.3 Reimbursement

1.1.4 Healthcare Spending

1.2 Selected European National Healthcare Profiles

1.2.1 France

1.2.1.1 Healthcare Organization and Reform

1.2.1.2 Hospital Services

1.2.1.3 Medical Device Reimbursement

1.2.2 Germany

1.2.2.1 Healthcare Organization and Reform

1.2.2.2 Hospital Services

1.2.2.3 Medical Device Reimbursement

1.2.3 Italy

1.2.3.1 Healthcare Organization and Reform

1.2.3.2 Hospital Services

1.2.3.3 Medical Device Reimbursement

1.2.4 Spain

1.2.4.1 Healthcare Organization and Reform

1.2.4.2 Hospital Services

1.2.4.3 Medical Device Reimbursement

1.2.5 United Kingdom

1.2.5.1 Healthcare Organization and Reform

1.2.5.2 Hospital Services

1.2.5.3 Medical Device Reimbursement

1.2.6 Benelux

1.2.6.1 Healthcare Organization and Reform

1.2.6.1.1 Belgium

1.2.6.1.2 Luxembourg

1.2.6.1.3 The Netherlands

1.2.6.2 Hospital Services

1.2.6.3 Medical Device Reimbursement

1.2.7 Nordic Countries

1.2.7.1 Healthcare Organization and Reform

1.2.7.1.1 Denmark

1.2.7.1.2 Finland

1.2.7.1.3 Norway

1.2.7.1.4 Sweden

1.2.7.2 Hospital Services

1.2.7.3 Medical Device Reimbursement


Exhibit 1-1: European Union, Medical Devices Risk Classification System

Exhibit 1-2: European Union Population Statistics Comparison for the Years 1996, 2006, and 2016

Exhibit 1-3: France, Selected National Healthcare Statistics

Exhibit 1-4: Germany, Selected National Healthcare Statistics

Exhibit 1-5: Italy, Selected National Healthcare Statistics

Exhibit 1-6: Spain, Selected National Healthcare Statistics

Exhibit 1-7: United Kingdom, Selected National Healthcare Statistics

Exhibit 1-8: Belgium, Selected National Healthcare Statistics

Exhibit 1-9: Luxembourg, Selected National Healthcare Statistics

Exhibit 1-10: The Netherlands, Selected National Healthcare Statistics

Exhibit 1-11: Denmark, Selected National Healthcare Statistics

Exhibit 1-12: Finland, Selected National Healthcare Statistics

Exhibit 1-13: Norway, Selected National Healthcare Statistics

Exhibit 1-14: Sweden, Selected National Healthcare Statistics

2. OVERVIEW OF HEART VALVE DISORDERS

2.1 Heart Anatomy and Physiology

2.1.1 The Cardiac Conduction System

2.1.2 The Heart Valves

2.1.2.1 Atrioventricular Valves

2.1.2.1.1 Tricuspid Valve

2.1.2.1.2 Mitral Valve

2.1.2.2 Semilunar Valves

2.1.2.2.1 Aortic Valve

2.1.2.2.2 Pulmonary Valve

2.2 Heart Valve Disorders

2.2.1 Types of Heart Valve Disorders

2.2.1.1 Valvular Stenosis

2.2.1.1.1 Aortic Valve Stenosis

2.2.1.1.2 Mitral Valve Stenosis

2.2.1.1.3 Tricuspid/Pulmonary Valve Stenosis

2.2.1.2 Valvular Regurgitation

2.2.1.2.1 Mitral Valve Regurgitation

2.2.1.2.2 Aortic Valve Regurgitation

2.2.1.2.3 Tricuspid/Pulmonary Valve Regurgitation

2.2.1.3 Valve Prolapse

2.2.2 Conditions Associated with Heart Valve Disorders

2.2.2.1 Congenital Defects

2.2.2.1.1 Ebstein’s Anomaly

2.2.2.1.2 Marfan Syndrome

2.2.2.1.3 Pulmonary Atresia

2.2.2.1.4 Tetralogy of Fallot

2.2.2.1.5 Tricuspid Atresia

2.2.2.2 Acquired Disorders

2.2.2.2.1 Calcific Degeneration

2.2.2.2.2 Infective Endocarditis

2.2.2.2.2.1 Acute Infective Endocarditis

2.2.2.2.2.2 Subacute Infective Endocarditis

2.2.2.2.3 Libman-Sacks Endocarditis

2.2.2.2.4 Myxomatous Degeneration

2.2.2.2.5 Rheumatic Fever

2.3 Heart Valve Disorder Treatment Strategies

2.3.1 Pharmaceutical Regimens

2.3.1.1 Anticoagulants and Antiplatelet Drugs

2.3.1.2 Anti-Arrhythmics

2.3.1.3 Diuretics

2.3.1.4 Vasodilators

2.3.1.5 Statins

2.3.2 Surgical Solutions

2.3.2.1 Techniques

2.3.2.1.1 Open-Heart Surgery

2.3.2.1.2 Minimally Invasive Surgery

2.3.2.1.3 Percutaneous Interventions

2.3.2.1.4 Robotic-Assisted Surgery

2.3.2.2 Heart Valve Repair

2.3.2.2.1 Annuloplasty

2.3.2.2.2 Balloon Valvuloplasty

2.3.2.3 Heart Valve Replacement


2.3.2.3.1 Types of Replacement Valves

2.3.2.3.1.1 Mechanical Valves

2.3.2.3.1.2 Tissue Valves


Exhibit 2-1: Cross-Section Diagram of the Normal Heart

Exhibit 2-2: Euro Heart Survey on Valvular Heart Disease Patient Population, Native Heart Valve Disorders, by Type

Exhibit 2-3: 2003, Rheumatic Heart Disease, Estimated Number of Reported Cases, by Selected Country/Region

Exhibit 2-4: Europe, Rheumatic Heart Disease Mortality, by Selected Country

Exhibit 2-5: Characteristics of the Ideal Prosthetic Heart Valve


3. EUROPEAN MARKETS FOR MECHANICAL HEART VALVES

3.1 Advantages of Mechanical Heart Valves

3.2 Disadvantages of Mechanical Heart Valves

3.3 Mechanical Heart Valve Designs

3.4 Mechanical Heart Valve Implantation, Procedure Volumes

3.5 Mechanical Heart Valves, Market Analysis

3.5.1 Products

3.5.2 Market Drivers

3.5.2.1 Reliability and Durability of Mechanical Heart Valves

3.5.2.2 Increasing Heart Valve Disorder Prevalence

3.5.2.3 Improvements in Heart Valve Disorder Diagnosis

3.5.2.4 Earlier Referrals for Heart Valve Replacement

3.5.3 Market Limiters

3.5.3.1 Mechanical Heart Valves as Commodity Items

3.5.3.2 Design Issues Associated with Mechanical Heart Valves

3.5.3.3 Advancements in Tissue Heart Valve Designs and Delivery Techniques

3.5.4 Combined Market Forecast

3.5.5 Country/Regional Market Forecasts

3.5.6 Competitive Analysis


Exhibit 3-1: Europe, Mechanical Heart Valve Implantation, Combined Procedure Volumes Forecast, 2003-2013

Exhibit 3-2: Europe, Mechanical Heart Valve Implantation, Procedure Volumes Forecast, by Country, 2003-2013

Exhibit 3-3: 2008, Selected Mechanical Heart Valves

Exhibit 3-4: Europe, Mechanical Heart Valves, Combined Market Forecast, 2003-2013

Exhibit 3-5: Europe, Mechanical Heart Valves, Market Forecast, by Country, 2003-2013

Exhibit 3-6: 2007, Country/Regional Percentages of the European Mechanical Heart Valves Market

Exhibit 3-7: France, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-8: Germany, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-9: Italy, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-10: Spain, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-11: United Kingdom, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-12: Benelux Countries, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-13: Nordic Countries, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-14: Rest of Europe, Mechanical Heart Valves, Market Forecast, 2003-2013

Exhibit 3-15: 2007, Europe, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-16: 2007, France, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-17: 2007, Germany, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-18: 2007, Italy, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-19: 2007, Spain, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-20: 2007, United Kingdom, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-21: 2007, Benelux Countries, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-22: 2007, Nordic Countries, Mechanical Heart Valves Market, Share by Supplier

Exhibit 3-23: 2007, Rest of Europe, Mechanical Heart Valves Market, Share by Supplier


4. EUROPEAN MARKETS FOR TISSUE HEART VALVES

4.1 Advantages of Tissue Heart Valves

4.2 Disadvantages of Tissue Heart Valves

4.3 Tissue Heart Valve Development

4.3.1 Autograft, Homograft, and Heterograft Valves

4.3.2 Stented versus Stentless Valves

4.3.3 Tissue Engineered Valves

4.4 Tissue Heart Valve Implantation, Procedure Volumes

4.5 Tissue Heart Valves, Market Analysis

4.5.1 Products

4.5.2 Market Drivers

4.5.2.1 Reduced Anticoagulant Requirements for Tissue Heart Valve Patients

4.5.2.2 Increased Longevity of Tissue Heart Valves

4.5.2.3 Increasing Heart Valve Disorder Prevalence

4.5.2.4 Introduction of Transcatheter and Minimally Invasive Heart Valve Replacement Procedures

4.5.3 Market Limiters

4.5.3.1 The Issue of Structural Valve Deterioration

4.5.3.2 Emerging Percutaneous Valve Repair Procedures

4.5.3.3 Potential Increase in the Utilization of Homograft Valves

4.5.3.4 Development of Tissue Engineered Heart Valves

4.5.4 Combined Market Forecast

4.5.5 Country/Regional Market Forecasts

4.5.6 Competitive Analysis


Exhibit 4-1: Europe, Tissue Heart Valve Implantation, Combined Procedure Volumes Forecast, 2003-2013

Exhibit 4-2: Europe, Tissue Heart Valve Implantations, Procedure Volumes Forecast, by Country, 2003-2013

Exhibit 4-3: 2008, Selected Tissue Heart Valves

Exhibit 4-4: Europe, Tissue Heart Valves, Combined Market Forecast, 2003-2013

Exhibit 4-5: Europe, Tissue Heart Valves, Market Forecast, by Country, 2003-2013

Exhibit 4-6: 2007, Country/Regional Percentages of the European Tissue Heart Valves Market

Exhibit 4-7: France, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-8: Germany, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-9: Italy, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-10: Spain, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-11: United Kingdom, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-12: Benelux Countries, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-13: Nordic Countries, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-14: Rest of Europe, Tissue Heart Valves, Market Forecast, 2003-2013

Exhibit 4-15: 2007, Europe, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-16: 2007, France, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-17: 2007, Germany, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-18: 2007, Italy, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-19: 2007, Spain, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-20: 2007, United Kingdom, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-21: 2007, Benelux Countries, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-22: 2007, Nordic Countries, Tissue Heart Valves Market, Share by Supplier

Exhibit 4-23: 2007, Rest of Europe, Tissue Heart Valves Market, Share by Supplier


5. EUROPEAN MARKETS FOR ANNULOPLASTY DEVICES

5.1 Heart Valve Repair Surgery

5.1.1 Annuloplasty

5.1.1.1 Annuloplasty Device Designs

5.2 Annuloplasty Device Implantation, Procedure Volumes

5.3 Annuloplasty Devices, Market Analysis

5.3.1 Products

5.3.2 Market Drivers

5.3.2.1 Increasing Heart Valve Disorder Prevalence

5.3.2.2 Recognized Undertreatment of Elderly Heart Valve Disorder Patients

5.3.2.3 Development/Emergence of Percutaneous Heart Valve Repair Technologies

5.3.3 Market Limiters

5.3.3.1 Delays in Payments to Heart Valve Repair Product Suppliers

5.3.3.2 Small Number of Heart Valve

Repair Product Suppliers

5.3.3.3 Development of Tissue Engineering

and Stem Cell Technologies

5.3.4 Combined Market Forecast

5.3.5 Country/Regional Market Forecasts

5.3.6 Competitive Analysis


Exhibit 5-1: 2008, Selected Design Characteristics of Annuloplasty Devices

Exhibit 5-2: Europe, Annuloplasty Device Implantation, Combined Procedure Volumes Forecast, 2003-2013

Exhibit 5-3: Europe, Annuloplasty Device Implantation, Procedure Volumes Forecast, by Country, 2007-2013

Exhibit 5-4: 2008, Selected Annuloplasty Products

Exhibit 5-5: Europe, Annuloplasty Devices, Combined Market Forecast, 2003-2013

Exhibit 5-6: Europe, Annuloplasty Devices, Market Forecast, by Country, 2003-2013

Exhibit 5-7: 2007, Country/Regional Percentages of the European Annuloplasty Devices Market

Exhibit 5-8: France, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-9: Germany, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-10: Italy, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-11: Spain, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-12: United Kingdom, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-13: Benelux Countries, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-14: Nordic Countries, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-15: Rest of Europe, Annuloplasty Devices, Market Forecast, 2003-2013

Exhibit 5-16: 2007, Europe, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-17: 2007, France, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-18: 2007, Germany, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-19: 2007, Italy, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-20: 2007, Spain, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-21: 2007, United Kingdom, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-22: 2007, Benelux Countries, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-23: 2007, Nordic Countries, Annuloplasty Devices Market, Share by Supplier

Exhibit 5-24: 2007, Rest of Europe, Annuloplasty Devices Market, Share by Supplier


6. COMPANY PROFILES

6.1 ATS Medical, Inc.

6.2 CoreValve, Inc.

6.3 CryoLife, Inc.

6.4 Edwards Lifesciences Corporation

6.5 Evalve, Inc.

6.6 Leman Cardiovascular SA

6.7 Maquet GmbH & Company KG/Getinge AB

6.8 Medical Carbon Research Institute LLC

6.9 Medtronic, Inc.

6.10 Mitralign, Inc.

6.11 Sorin Group SPA

6.12 St. Jude Medical, Inc.

6.13 Vascutek LTD/Terumo Corporation

6.14 Viacor, Inc.

APPENDIX: COMPANY LISTING

Abstract

As the sizable European population both grows and ages, the number of people in the region living with congenital or acquired heart valve disorders continues to increase.

In 2007, more than 81,000 heart valve repair/replacement procedures were performed in Europe. These procedures generated approximately $246.4 million in total sales of annuloplasty devices for heart valve repair, and mechanical and tissue heart valves for heart valve replacement. Growing at a compound annual rate of 3.9%, combined sales of heart valve repair and replacement products are projected to reach an estimated $310.4 million in the year 2013.

This dynamic, new report from Medtech Insight includes analyses of products, current and emerging markets, competitors, and opportunities in the European heart valve repair and replacement products market.

Covered topics in this report include a discussion of the healthcare markets of France, Germany, Italy, Spain, the U.K., the Benelux countries, and the Nordic countries; annuloplasty procedures and devices; autograft and homograft valves; bovine, equine, and porcine heterograft valves; mechanical heart valve products and procedures; open-heart, percutaneous, minimally invasive, and robotic-assisted approaches to heart valve repair and replacement; an overview of heart valve disorders and management options; pharmaceutical products for the treatment of heart valve disorders; stented versus stentless heart valves; tissue engineered heart valves, and tissue heart valve products and procedures.

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