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European Markets for Heart Valve Repair and Replacement Products
Report #A261 - January 2012
340 Pages – 81 Exhibits – 17 Company Profiles

It is projected that between the years 2010 and 2020, the population in the European Union (EU) will increase from approximately 502 million to an estimated 511 million, and that by the year 2020, 20.2% of the population will be age 65 or older. The growing pool of older people living in the EU with heart valve disorders such as age-related aortic valve degeneration and symptomatic mitral valve regurgitation will continue to boost demand for heart valve repair and replacement procedures in the region for the foreseeable future.

Together, heart valve repair/replacement procedures generated an estimated $827.5 million in corresponding product sales in Europe in 2010. It is expected that during the forecast period covered by this report, sales of heart valve repair/replacement products in Europe will increase at a compound annual rate of 10.7%, reaching an estimated $1,375.3 million in the year 2015.

This dynamic, new report from Medtech Insight includes analyses of products, current and forecast markets, competitors, and opportunities for suppliers of heart valve repair/replacement products to Europe

Covered topics in this report include an a discussion of the healthcare markets of France, Germany, Italy, Spain, the U.K., and the Benelux countries; an overview of heart valve disorders and heart valve repair/replacement technologies; annuloplasty rings, bands, and accessories; autograft and homograft heart valves; bovine, equine, and porcine heterograft heart valves; emerging and existing transcatheter and less invasive heart valve repair/replacement products; mechanical heart valve replacement procedures and products; percutaneous balloon valvuloplasty procedures and products; pharmaceutical products used in the treatment of patients with cardiovascular disorders; surgical and transcatheter heart valve repair/replacement procedures; tissue engineering related to the development of autologous heart valves; and tissue heart valve replacement procedures and products, among others.

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European Markets for Heart Valve Repair and Replacement Products

A261

January 2012

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Methodology

Reports are produced exclusively by Medtech Insight, through extensive primary and secondary research among the clinicians, researchers, and competitors in the marketplace, and draw upon the industry expertise of a network of industry insiders. Medtech Insight exhaustively corroborates the data as a baseline for completing forward-looking analysis and providing insight into product, technology and market evolution.

 

TABLE OF CONTENTS

 

EXECUTIVE SUMMARY

i.      Heart Valve Replacement Systems Market

a.     Mechanical Heart Valve Replacement Systems Market Segment

b.     Tissue Heart Valve Replacement Systems Market Segment

ii.     Heart Valve Repair Systems Market

iii.    Methodology

 

Exhibit ES-1:    European Union Population Statistics Comparison for the Years 2000, 2010, and 2020

Exhibit ES-2:    2010, Percentage of the Total Population Age 65 or Older, Selected European Countries

Exhibit ES-3:    Europe, Heart Valve Repair/Replacement, Combined Procedure Volumes Forecast, 2010-2015

Exhibit ES-4:    Europe, Heart Valve Repair/Replacement Systems, Combined Market Forecast, 2010-2015

Exhibit ES-5:    Europe, Mechanical Heart Valve Replacement, Combined Procedure Volumes Forecast, 2010-2015

Exhibit ES-6:    Europe, Mechanical Heart Valve Replacement, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit ES-7:    Europe, Mechanical Heart Valve Replacement Systems, Combined Market Forecast, 2010-2015

Exhibit ES-8:    Europe, Mechanical Heart Valve Replacement Systems, Market Forecast, by Country, 2010-2015

Exhibit ES-9:    Europe, Tissue Heart Valve Replacement, Combined Procedure Volumes Forecast, 2010-2015

Exhibit ES-10:  Europe, Tissue Heart Valve Replacement, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit ES-11:  Europe, Tissue Heart Valve Replacement Systems, Combined Market Forecast, 2010-2015

Exhibit ES-12:  Europe, Tissue Heart Valve Replacement Systems, Market Forecast, by Country, 2010-2015

Exhibit ES-13:  Europe, Heart Valve Repair, Combined Procedure Volumes Forecast, 2010-2015

Exhibit ES-14:  Europe, Heart Valve Repair, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit ES-15:  Europe, Heart Valve Repair Systems, Combined Market Forecast, 2010-2015

Exhibit ES-16:  Europe, Heart Valve Repair Systems, Market Forecast, by Country, 2010-2015

 

1. SELECTED EUROPEAN HEALTHCARE MARKETS

1.1 The European Union

1.1.1 A Common Currency

1.1.1.1 Sovereign Debt Crises/Bailout Loans

1.1.1.1.1 Greece

1.1.1.1.2 Ireland

1.1.1.1.3 Portugal

1.1.2 Late Payments Directive

1.1.3 Regulatory Policies

1.1.4 Reimbursement

1.1.5 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 Services/Supplies Reimbursement

1.2.2 Germany

1.2.2.1 Healthcare Organization and Reform

1.2.2.2 Hospital Services

1.2.2.3 Medical Services/Supplies Reimbursement

1.2.3 Italy

1.2.3.1 Healthcare Organization and Reform

1.2.3.2 Hospital Services

1.2.3.3 Medical Services/Supplies Reimbursement

1.2.4 Spain

1.2.4.1 Healthcare Organization and Reform

1.2.4.2 Hospital Services

1.2.4.3 Medical Services/Supplies 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 Services/Supplies Reimbursement

1.2.6 Benelux Countries

1.2.6.1 Healthcare Organization and Reform

1.2.6.1.1 Belgium

1.2.6.1.2 Netherlands

1.2.6.1.3 Luxembourg

1.2.6.2 Hospital Services

1.2.6.3 Medical Services/Supplies Reimbursement

 

Exhibit 1-1:      2012, Map of the European Union

Exhibit 1-2:      European Union, Medical Devices Risk Classification System

Exhibit 1-3:      European Union Population Statistics Comparison for the Years 2000, 2010, and 2020

Exhibit 1-4:      2010, Percentage of the Total Population Age 65 or Older, Selected Countries

Exhibit 1-5:      2010, Gross Domestic Product per Capita, Selected Countries

Exhibit 1-6:      2008, Healthcare Expenditures as a Percentage of Gross Domestic Product, Selected Countries

Exhibit 1-7:      2012, Map of France

Exhibit 1-8:      France, Selected National Healthcare Statistics

Exhibit 1-9:      2012, Map of Germany

Exhibit 1-10:    Germany, Selected National Healthcare Statistics

Exhibit 1-11:    2012, Map of Italy

Exhibit 1-12:    Italy, Selected National Healthcare Statistics

Exhibit 1-13:    2012, Map of Spain

Exhibit 1-14:    Spain, Selected National Healthcare Statistics

Exhibit 1-15:    2012, Map of the United Kingdom

Exhibit 1-16:    United Kingdom, Selected National Healthcare Statistics

Exhibit 1-17:    2012, Map of Belgium

Exhibit 1-18:    2012, Map of the Netherlands

Exhibit 1-19:    2012, Map of Luxembourg

Exhibit 1-20:    Belgium, Selected National Healthcare Statistics

Exhibit 1-21:    Netherlands, Selected National Healthcare Statistics

Exhibit 1-22:    Luxembourg, Selected National Healthcare Statistics

 

2. OVERVIEW OF HEART VALVE DISORDERS AND REPAIR/REPLACEMENT PROCEDURES

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/Mitral Valve Stenosis

2.2.1.1.2 Tricuspid Valve/Pulmonary Valve Stenosis

2.2.1.2 Valvular Regurgitation

2.2.1.2.1 Aortic Valve/Mitral Valve Regurgitation

2.2.1.2.2 Tricuspid Valve/Pulmonary Valve Regurgitation

2.2.1.2.3 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 Antithrombotics

2.3.1.1.1 Anticoagulants

2.3.1.1.2 Antiplatelets

2.3.1.2 Antiarrhythmics

2.3.1.3 Diuretics

2.3.1.4 Vasodilators

2.3.1.5 Statins

2.3.2 Surgical/Interventional Solutions

2.3.2.1 Techniques

2.3.2.1.1 Open Heart Surgery

2.3.2.1.2 Less Invasive Techniques

2.3.2.1.3 Interventional Methods

2.3.2.2 Heart Valve Repair

2.3.2.2.1 Annuloplasty

2.3.2.2.2 Percutaneous Balloon Valvuloplasty

2.3.2.2.3 Transcatheter Mitral Valve Repair Techniques

2.3.2.3 Heart Valve Replacement

2.3.2.3.1 Types of Replacement Valves

2.3.2.3.1.1 Mechanical Heart Valves

2.3.2.3.1.2 Tissue Heart Valves

 

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

Exhibit 2-2:      Cross-Section Diagram of the Heart Valves

Exhibit 2-3:      Euro Heart Survey on Valvular Heart Disease Patient Population, Native Heart Valve Disorders, by Type

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

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

 

3. MECHANICAL HEART VALVE REPLACEMENT SYSTEMS MARKET

3.1 Mechanical Heart Valve Replacement Systems, Development/Design

3.2 Mechanical Heart Valve Replacement Systems, Market Analysis

3.2.1 Market Drivers

3.2.2 Market Limiters

3.2.3 Products

3.2.4 Procedure Volumes

3.2.5 Market Forecast

3.2.6 Competitive Analysis

3.2.6.1 ATS Medical/Medtronic

3.2.6.2 On-X Life Technologies

3.2.6.3 Sorin Group

3.2.6.4 St. Jude Medical

 

Exhibit 3-1:      2012, Selected Mechanical Heart Valve Replacement Systems

Exhibit 3-2:      Europe, Mechanical Heart Valve Replacement, Combined Procedure Volumes Forecast, 2010-2015

Exhibit 3-3:      Europe, Mechanical Heart Valve Replacement, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit 3-4:      Europe, Mechanical Heart Valve Replacement Systems, Combined Market Forecast, 2010-2015

Exhibit 3-5:      Europe, Mechanical Heart Valve Replacement Systems, Market Forecast, by Country, 2010-2015

Exhibit 3-6:      France, Mechanical Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 3-7:      Germany, Mechanical Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 3-8:      Italy, Mechanical Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 3-9:      Spain, Mechanical Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 3-10:    United Kingdom, Mechanical Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 3-11:    Benelux Countries, Mechanical Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 3-12:    2010, Mechanical Heart Valve Replacement Systems Market, Share by Supplier

 

4. TISSUE HEART VALVE REPLACEMENT SYSTEMS MARKET

4.1 Tissue Heart Valve Replacement Systems, Development/Design

4.1.1 Autograft, Homograft, and Heterograft Valves

4.1.2 Stented versus Stentless Valves

4.1.3 Tissue-Engineered Valves

4.1.3.1 CryoLife

4.1.3.2 LifeCell/Kinetic Concepts

4.1.3.3 AutoTissue

4.1.3.4 Tepha

4.2 Tissue Heart Valve Replacement Systems, Market Analysis

4.2.1 Market Drivers

4.2.2 Market Limiters

4.2.3 Products

4.2.4 Procedure Volumes

4.2.5 Market Forecast

4.2.6 Competitive Analysis

4.2.6.1 Surgical Tissue Heart Valve Suppliers

4.2.6.1.1 ATS Medical/Medtronic

4.2.6.1.2 CryoLife Europa/CryoLife

4.2.6.1.3 Edwards Lifesciences

4.2.6.1.4 Medtronic

4.2.6.1.5 Sorin Group

4.2.6.1.6 St. Jude Medical

4.2.6.1.7 Vascutek/Terumo Group

4.2.6.2 Transcatheter Tissue Heart Valve Developers

4.2.6.2.1 Direct Flow Medical

4.2.6.2.2 Edwards Lifesciences

4.2.6.2.3 JenaValve Technology

4.2.6.2.4 Medtronic

4.2.6.2.5 Sadra Medical/Boston Scientific

4.2.6.2.6 St. Jude Medical

4.2.6.2.7 Symetis

4.2.6.2.8 Transcatheter Technologies

4.2.6.2.9 ValveXchange

 

Exhibit 4-1:      2012, Selected Tissue Heart Valve Replacement Systems

Exhibit 4-2:      Europe, Tissue Heart Valve Replacement, Combined Procedure Volumes Forecast, 2010-2015

Exhibit 4-3:      Europe, Tissue Heart Valve Replacement, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit 4-4:      Europe, Transcatheter Tissue Heart Valve Replacement, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit 4-5:      Europe, Surgical Tissue Heart Valve Replacement, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit 4-6:      Europe, Tissue Heart Valve Replacement Systems, Combined Market Forecast, 2010-2015

Exhibit 4-7:      Europe, Tissue Heart Valve Replacement Systems, Market Forecast, by Country, 2010-2015

Exhibit 4-8:      France, Tissue Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 4-9:      Germany, Tissue Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 4-10:    Italy, Tissue Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 4-11:    Spain, Tissue Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 4-12:    United Kingdom, Tissue Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 4-13:    Benelux Countries, Tissue Heart Valve Replacement Systems, Market Forecast, 2010-2015

Exhibit 4-14:    2010, Tissue Heart Valve Replacement Systems Market, Share by Supplier

 

5. HEART VALVE REPAIR SYSTEMS MARKET

5.1 Heart Valve Repair Systems, Development/Design

5.1.1 Annuloplasty Devices

5.1.2 Percutaneous Balloon Valvuloplasty Devices

5.1.3 Transcatheter/Less Invasive Heart Valve Repair Devices

5.2 Heart Valve Repair Systems, Market Analysis

5.2.1 Market Drivers

5.2.2 Market Limiters

5.2.3 Products

5.2.4 Procedure Volumes

5.2.5 Market Forecast

5.2.6 Competitive Analysis

5.2.6.1 Surgical and Transcatheter/Less Invasive Heart Valve Repair Device Suppliers

5.2.6.1.1 Abbott Vascular/Abbott Laboratories

5.2.6.1.2 ATS Medical/Medtronic

5.2.6.1.3 Cardiac Dimensions

5.2.6.1.4 Edwards LIfesciences

5.2.6.1.5 Medtronic

5.2.6.1.6 MiCardia

4.2.6.1.7 Mitralign

5.2.6.1.8 Sorin Group

5.2.6.1.9 St. Jude Medical

5.2.6.2 Percutaneous Balloon Valvuloplasty Device Suppliers

5.2.6.2.1 NuMED

5.2.6.2.2 Toray Industries/Toray Group

 

Exhibit 5-1:      2012, Selected Heart Valve Repair Systems

Exhibit 5-2:      Europe, Heart Valve Repair, Combined Procedure Volumes Forecast, 2010-2015

Exhibit 5-3:      Europe, Heart Valve Repair, Procedure Volumes Forecast, by Country, 2010-2015

Exhibit 5-4:      Europe, Heart Valve Repair Systems, Combined Market Forecast, 2010-2015

Exhibit 5-5:      Europe, Heart Valve Repair Systems, Market Forecast, by Country, 2010-2015

Exhibit 5-6:      France, Heart Valve Repair Systems, Market Forecast, 2010-2015

Exhibit 5-7:      Germany, Heart Valve Repair Systems, Market Forecast, 2010-2015

Exhibit 5-8:      Italy, Heart Valve Repair Systems, Market Forecast, 2010-2015

Exhibit 5-9:      Spain, Heart Valve Repair Systems, Market Forecast, 2010-2015

Exhibit 5-10:    United Kingdom, Heart Valve Repair Systems, Market Forecast, 2010-2015

Exhibit 5-11:    Benelux Countries, Heart Valve Repair Systems, Market Forecast, 2010-2015

Exhibit 5-12:    2010, Heart Valve Repair Systems Market, Share by Supplier

 

6. COMPANY PROFILES

6.1       Abbott Vascular/Abbott Laboratories

6.2       ATS Medical/Medtronic, Inc.

6.3       Cardiac Dimensions, Inc.

6.4       CryoLife Europa/CryoLife, Inc.

6.5       Edwards Lifesciences Corporation

6.6       JenaValve Technololgy GmbH

6.7       Medtronic, Inc.

6.8       MiCardia Corporation

6.9       NuMED, Inc.

6.10     On-X Life Technologies, Inc.

6.11     Sorin Group SpA

6.12     St. Jude Medical, Inc.

6.13     Symetis SA

6.14     Toray Industries/Toray Group

6.15     TranscatheterTechnologies GmbH

6.16     ValveXchange, Inc.

6.17     Vascutek LTD/Terumo Group

 

APPENDIX:  COMPANY LISTING

 

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