The economic cost of cardiovascular disease (CVD) and stroke, a potential consequence of CVD, is of staggering proportions, estimated by the American Heart Association and the National Heart, Lung, and Blood Institute to be $403.1 billion in 2006. As a result of such high demand the cardiovascular segment is one of the most fiercely fought over by medical device companies which are investing heavily in device-based therapies that have the capability to cost effectively treat CVD patients.

Competition between medical device companies in the market is increasingly intense and as a consequence merger and acquisition activity rose dramatically in the sector in 2006 and has continued into 2007. Part of this rise can be attributed to an expanding US economy, increases in corporate profits and stock prices, technological improvements, and growing product demand. The large cardiovascular deals in 2006 were Boston Scientific taking Guidant in a landmark $27 billion deal, the acquisition of Guidant' s vascular and endovascular businesses by Abbott for $4.1 billion and J&J' s purchase of stent maker Conor Medsystems for $1.4 billion. However there have been a number of smaller but also significant deals such as ATS Medical, in a bid to flesh out its cardiac surgery product line, acquiring 3F Therapeutics, an early-stage company specialising in minimally-invasive, beating heart tissue valve replacements, and, in 2007 acquiring the surgical cryoablation business of CryoCath Technologies.

The two big sectors of the cardiovascular market where there are the most valuable markets to conquer are coronary stents and cardiac rhythm management devices.

This report examines the impact of new technologies and the growth of the various sectors of the cardiovascular device market in addition to describing the main geographical markets and the emerging ones such as India, South East Asia, China, which, due to their rapid economic growth are attracting the attention of market players of all sizes. However gaining access to a market with a novel or even a "me too" cardiovascular device is no easy procedure as, in addition to being costly products to reimburse, they frequently fall into the highest of the risk class of devices and the report therefore examines the barriers and procedures required for entering these markets.

CHAPTER 1 INTRODUCTION

1.1 Aims of the report
1.2 Scope of the report
- 1.2.1 Products included
- 1.2.2 Markets included
- 1.2.3 Years covered
- 1.2.4 Methodology
- 1.2.5 Forecasting
1.3 Conditions influencing the cardiovascular market
1.4 Lifestyle issues
1.5 Emerging markets
1.6 Regulation and reimbursement issues
1.7 Safety issues
1.8 Emergence of devices vs drugs
1.9 Cardiovascular device manufacturers
1.10 Technology trends

CHAPTER 2 MARKET OVERVIEW

2.1.1 Drivers and limiters

CHAPTER 3 CARDIAC RHYTHM MANAGEMENT

3.1 Cardiac rhythm background
3.2 Arrhythmias
- 3.2.1 Types of arrhythmia
  - 3.2.1.1 Bradycardia
  - 3.2.1.2 Tachycardia
  - 3.2.1.3 Ventricular fibrillation
  - 3.2.1.4 Atrial fibrillation
  - 3.2.1.5 Tachyarrhythmias
  - 3.2.1.6 Bradytachycardia
  - 3.2.1.7 Heart block
  - 3.2.1.8 Premature ventricular contractions
3.3 Diagnosis of arrhythmias
3.4 Drug therapy
3.5 Pacemakers
- 3.5.1 Single-chamber pacemakers
- 3.5.2 Dual-chamber pacemakers
- 3.5.3 Rate responsive pacemakers
- 3.5.4 Cardiac resynchronisation therapy pacemaker
- 3.5.5 Programming
- 3.5.6 New clinical applications of pacemakers
- 3.5.7 Companies and products
  - 3.5.7.1 Biotronik
  - 3.5.7.2 Boston Scientific
  - 3.5.7.3 Medtronic
  - 3.5.7.4 Sorin Group
  - 3.5.7.5 St Jude Medical
- 3.5.8 Factors driving growth
- 3.5.9 Market data
3.6 Implantable cardioverter defibrillators
- 3.6.1 Effectiveness and clinical studies
- 3.6.2 New clinical applications
- 3.6.3 Companies and products
  - 3.6.3.1 Biotronik
  - 3.6.3.2 Boston Scientific
  - 3.6.3.3 Medtronic
  - 3.6.3.4 Sorin Group
  - 3.6.3.5 St Jude Medical
- 3.6.4 Factors driving growth
- 3.6.5 Market data
3.7 Automatic external defibrillators
- 3.7.1 Effectiveness and clinical studies
- 3.7.2 Companies and products
  - 3.7.2.1 Cardiac Science
  - 3.7.2.2 GE Healthcare
  - 3.7.2.3 Medtronic
  - 3.7.2.4 Philips Medical
  - 3.7.2.5 Schiller
  - 3.7.2.6 Zoll
- 3.7.3 Market data
3.8 Pacemaker and defibrillator programmers
- 3.8.1 Companies and products
  - 3.8.1.1 Biotronik
  - 3.8.1.2 Boston Scientific
  - 3.8.1.3 Medtronic
  - 3.8.1.4 St Jude Medical
  - 3.8.1.5 Sorin
- 3.8.2 Market dynamics
3.9 Cardiac ablation devices
- 3.9.1 Companies and products
  - 3.9.1.1 Boston Scientific
  - 3.9.1.2 CryoCath Technologies
  - 3.9.1.3 CryoCor
  - 3.9.1.4 Medtronic
  - 3.9.1.5 St Jude Medical
  - 3.9.1.6 Factors driving growth
- 3.9.2 Market data

CHAPTER 4 CORONARY ARTERY DISEASE

4.1 Myocardial infarction
4.2 Acute myocardial infarction
4.3 Post-myocardial infarction
- 4.3.1 First line therapies
  - 4.3.1.1 Beta-blockers
  - 4.3.1.2 ACE Inhibitors
  - 4.3.1.3 Aspirin
  - 4.3.1.4 Thrombolytic therapy
4.4 Diagnosis
- 4.4.1 Cardiac markers
- 4.4.2 Intravascular ultrasound
- 4.4.3 Magnetic resonance imaging
- 4.4.4 Computed tomography imaging
- 4.4.5 Catheters
4.5 Surgery
- 4.5.1 Coronary artery bypass graft surgery
- 4.5.2 Anastomosis devices
- 4.5.3 Robotic surgery
- 4.5.4 Beating heart surgery devices
- 4.5.5 Factors driving growth
- 4.5.6 Market data
4.6 Angioplasty devices
- 4.6.1 Factors driving growth
- 4.6.2 Market
4.7 Stents
- 4.7.1 Stent types
- 4.7.2 Stent delivery
- 4.7.3 Companies and products
- 4.7.4 Factors driving growth
- 4.7.5 Market data
4.8 Embolic protection systems
- 4.8.1 Factors driving growth
- 4.8.2 Market data

CHAPTER 5 HEART VALVE DISORDERS

5.1 Introduction
5.2 Valve repair annuloplasty devices
- 5.2.1 Products
5.3 Mechanical valves
5.4 Tissue valves
- 5.4.1 Human tissue valves
- 5.4.2 Animal tissue valves
5.5 PFO devices and devices for closing other types of holes in the heart
- 5.5.1 Patent foramen ovale
- 5.5.2 Patent ductus arteriosus
- 5.5.3 Ventricular septal defects
5.6 Factors driving growth
5.7 Market data

CHAPTER 6 END-STAGE HEART FAILURE

6.1 Available therapies
- 6.1.1 Angiotensin receptor blockers (ARBs)
- 6.1.2 Beta-blockers
- 6.1.3 Digoxin
- 6.1.4 Diuretics
- 6.1.5 Aldosterone antagonists
- 6.1.6 Left ventricular reduction surgery
- 6.1.7 Intra-aortic balloon pumps
- 6.1.8 Ventricular reshaping devices
- 6.1.9 Ventricular assist devices
- 6.1.10 Artificial hearts
6.2 Companies and products
- 6.2.1 Abiomed
- 6.2.2 Arrow International
- 6.2.3 Berlin Heart
- 6.2.4 CardiacAssist
- 6.2.5 MicroMed Technology
- 6.2.6 Jarvik Heart
- 6.2.7 MEDOS Medizintechnik AG
- 6.2.8 SynCardiac Systems
- 6.2.9 Thoratec
- 6.2.10 Ventracor
- 6.2.11 WorldHeart
6.3 Factors driving growth
6.4 Market data

CHAPTER 7 MARKET ANALYSIS BY COUNTRY

7.1 The US
- 7.1.1 Customer profile
- 7.1.2 Regulations
- 7.1.3 Reimbursement
- 7.1.4 CRM device market
- 7.1.5 Coronary artery disease device market
- 7.1.6 Valve disorders market
- 7.1.7 Congestive heart failure device market
7.2 Japan
- 7.2.1 Customer profile
- 7.2.2 Regulations
- 7.2.3 Reimbursement
  - 7.2.3.1 Type A
  - 7.2.3.2 Type B
  - 7.2.3.3 Type C
  - 7.2.3.4 Type F
- 7.2.4 CRM device market
- 7.2.5 Coronary artery disease device market
- 7.2.6 Valve disorders market
- 7.2.7 Congestive heart failure device market
7.3 Germany
- 7.3.1 Customer profile
- 7.3.2 Regulations
- 7.3.3 Reimbursement
- 7.3.4 CRM device market
- 7.3.5 Coronary artery disease device market
- 7.3.6 Valve disorders market
- 7.3.7 Congestive heart failure device market
7.4 France
- 7.4.1 Customer profile
- 7.4.2 Regulations
- 7.4.3 Reimbursement
- 7.4.4 CRM device market
- 7.4.5 Coronary artery disease device market
- 7.4.6 Valve disorders market
- 7.4.7 Congestive heart failure device market
7.5 The UK
- 7.5.1 Customer profile
- 7.5.2 Regulations
- 7.5.3 Reimbursement
- 7.5.4 CRM device market
- 7.5.5 Coronary artery disease device market
- 7.5.6 Valve disorders market
- 7.5.7 Congestive heart failure device market
7.6 Italy
- 7.6.1 Customer profile
- 7.6.2 Regulations
- 7.6.3 Reimbursement
- 7.6.4 CRM device market
- 7.6.5 Coronary artery disease device market
- 7.6.6 Valve disorders market
- 7.6.7 Congestive heart failure device market
7.7 Spain
- 7.7.1 Customer profile
- 7.7.2 Regulations
- 7.7.3 Reimbursement
- 7.7.4 CRM device market
- 7.7.5 Coronary artery disease device market
- 7.7.6 Valve disorders market
- 7.7.7 Congestive heart failure device market
7.8 China
- 7.8.1 Customer profile
- 7.8.2 Regulations
- 7.8.3 Reimbursement
- 7.8.4 CRM device market
- 7.8.5 Coronary artery disease device market
- 7.8.6 Valve disorders market
- 7.8.7 Congestive heart failure device market
7.9 India
- 7.9.1 Customer profile
- 7.9.2 Regulations
- 7.9.3 Reimbursement
- 7.9.4 CRM device market
- 7.9.5 Coronary artery disease device market
- 7.9.6 Valve disorders market
- 7.9.7 Congestive heart failure device market
7.10 The rest of the world
- 7.10.1 South America
  - 7.10.1.1 Customer profile
  - 7.10.1.2 Argentina
  - 7.10.1.3 Brazil
  - 7.10.1.4 Chile
  - 7.10.1.5 Columbia
  - 7.10.1.6 Mexico
  - 7.10.1.7 Peru
  - 7.10.1.8 Venezuela
- 7.10.2 South East Asia
  - 7.10.2.1 Customer profile
  - 7.10.2.2 Indonesia
  - 7.10.2.3 Malaysia
  - 7.10.2.4 Philippines
  - 7.10.2.5 Singapore
  - 7.10.2.6 South Korea
  - 7.10.2.7 Taiwan
  - 7.10.2.8 Thailand
  - 7.10.2.9 Vietnam
- 7.10.3 Australia
  - 7.10.3.1 Customer profile
  - 7.10.3.2 Regulations
  - 7.10.3.3 Reimbursement
  - 7.10.3.4 The market

CHAPTER 8 COMPANY PROFILES

LIST OF TABLES

Table 1.1 Prevalence of hypertension in major medical device markets 2004-2011
Table 2.1 US Versus non-US sales of key industry players in 2006
Table 2.2 Cardiac rhythm management
Table 2.3 Interventional cardiology
Table 2.4 Stents
Table 2.5 Angioplasty balloons and catheters
Table 2.6 Vascular closure devices
Table 3.1 Major suppliers of pacemakers and their brands
Table 3.2 Pacemaker prices in 2005 ($)
Table 3.3 European pacing centres per million population
Table 3.4 European countries with the highest rates of implanted pacemakers per million population, in 2005
Table 3.5 European countries with the lowest rates of implanted pacemakers per million population in 2005
Table 3.6 Major suppliers of ICDs and their brands
Table 4.1 MRI and CT installed base per million of population
Table 4.2 Trends in average costs by hospital procedure and volume 1988-2000
Table 6.1 ACC/AHA Classification of chronic heart failure
Table 6.2 New York Heart Association Heart Failure Symptom Classification System
Table 6.3 Principal indications for intra-aortic balloon pump
Table 6.4 VAD by manufacturer 2007
Table 7.1 Cardiovascular operations (thousands) in the US in 2004
Table 7.2 Estimated direct costs ($ billion) of cardiovascular disease and Stroke, U.S. 2004
Table 7.3 510(k) v PMA approval process in the US
Table 7.4 Cardiovascular HRGs in the UK

LIST OF FIGURES

Figure 1.1 Deaths by cause 2005
Figure 2.1 Medical device market by sector 2007
Figure 2.2 Segmentation of cardiovascular market 2007
Figure 2.3 Segmentation of cardiovascular market 2011
Figure 3.1 Value of the world pacemaker market ($ millions)
Figure 3.2 Company share of the world pacemaker market 2007
Figure 3.3 Value of the world ICD market ($ millions)
Figure 3.4 Company share of the world ICD market 2007
Figure 3.5 Value of the world AED market ($ millions)
Figure 3.6 Company share of the world AED market 2007
Figure 3.7 Value of the world cardiac ablation market ($ millions)
Figure 3.8 Company share of the world cardiac ablation market 2007
Figure 4.1 Value of the world cardiac surgical equipment & tools market ($ millions)
Figure 4.2 Value of the world bypass & disposables market ($ millions)
Figure 4.3 Value of the world minimally invasive coronary artery bypass market ($ millions)
Figure 4.4 Value of the world angioplasty and balloon catheter market ($ millions)
Figure 4.5 Value of the world bare metal stent market ($ millions)
Figure 4.6 Value of the world drug eluting stent market ($ millions)
Figure 4.7 Value of the world embolic protection market ($ millions)
Figure 5.1 Value of the world tissue heart valve market $ millions
Figure 5.2 Company share of the world tissue heart valve market 2007
Figure 5.3 Value of the world mechanical heart valve market $ millions
Figure 5.4 Company share of the world mechanical heart valve market 2007
Figure 5.5 Value of the world heart valve repair market $ millions
Figure 5.6 Company share of the world heart valve repair market 2007
Figure 6.1 Value of the world VAD market $ millions
Figure 6.2 Value of the world intra aortic balloon pump market $millions