Ventricular Assist Devices

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations
• Disclaimers
• Data Interpretation & Reporting Level
• Quantitative Techniques & Analytics
• Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. Introduction

• Global & Regional Market Analysis
• Opportunities in VAD Market
• Destination Therapy - An Immense Potential Opportunity
• Next Generation Devices to Offer Pronounced Scope
• Heart Transplantation Scenario
• Table 1: Number of Heart Transplants Worldwide (2000-2006) (In Units) (includes corresponding Graph/Chart)
• Table 2: Heart Transplants Worldwide (2008E): Percentage Share Breakdown by Country/Region (includes corresponding Graph/Chart)

2. Competition

• Thoratec is the Clear Leader
• Leading Players in the Global VAD Market
• Table 3: Leading Players in the Global VAD and Circulatory Support Market (2007): Percentage Breakdown of Value Sales for Thoratec, Abiomed, WorldHeart and Others (includes corresponding Graph/Chart)
• Table 4: Global VAD Market (2007): Implantations in Units by Select Player - Thoratec, MicroMed Cardiovascular, Berlin Heart, Ventracor, Terumo Heart and HeartWare (includes corresponding Graph/Chart)
• Competition Heats Up
• Competitive Technologies

3. VAD - An Insight

• Heart - The Vital Organ
• Heart Diseases
• Congenital Heart Disease
• Congestive Heart Failure
• Mechanical Circulatory Support Systems
• Total Artificial Heart
• VADs
• VADs Usage by Indication and Time Duration
• Types
• VAD Components
• VAD Pumps
• Li-Ion Batteries: Reliable Power Sources for Portable Medical Devices
• Implantation Procedure
• Aftercare
• Complications
• Infection
• Internal Bleeding
• Thrombus
• Table 5: Percentage Breakdown of Possible Complications in VADs Usage by Type - Infection, Bleeding, Arrhythmia, Renal Dysfunction, Respiratory Dysfunction, Neurologic Dysfunction, RV Dysfunction and Others (includes corresponding Graph/Chart)
• Pricing of VAD
• Table 6: Average Selling Prices of Select VADs by Company and Model
• VAD Improvisations
• LVADs - An Introduction
• LVAD Milestones
• An Effective Therapeutic Device for End-Stage Congestive Heart Failure
• Ventricular Assistance Vs. Heart Replacement

4. An Insight into the First, Second and Third

• First Generation VAD
• Second Generation VAD
• Rotary Axial Flow Pumps
• Drawbacks of Axial Flow Pump
• Third Generation VAD
• Select First, Second and Third Generation Implantable VADs

5. Reimbursement Scenario

• Government Regulations
• The US
• Canada
• Europe

6. Product Approvals/Innovations/Introductions

• Thoratec Receives FDA Approval for its HeartMate II LVAS
• HeartWare Receives Conditional Approval for its HeartWare LVAS
• Abiomed Receives CE Mark for AB5000 Portable Driver
• Ventracor Receives USFDA Approval to Use its VentrAssist Device in Clinical Trials
• NewCorTec Launches a New LVAD
• WorldHeart Launches New Pediatric VAD
• Ventracor Obtains FDA Approval for VentrAssist' s US BTT Trial
• MicroMed Cardiovascular Obtains 5-Year CE Mark Extension for DeBakey
• Thoratec Submits PMA for HeartMate II Left Ventricular Assist System
• Ventracor Receives ' Commercial Ready' Grant to Develop VentrAssist LVAD
• Terumo Heart Obtains CE Mark for its DuraHeart(r) LVAS in Europe
• Abiomed Acquires Regulatory Approval in Australia for Impella LP 2.5 LVAD
• Abiomed Receives FDA Approval for Impella 2.5 VAD Pilot Trials
• Biophan Develops New MYO-VAD
• Queensland University of Technology Invents Counter-Flow Pump
• HeartWare Obtains German Regulatory Approval for its HVAD(tm)
• Abiomed Receives Regulatory Approval in France for its AB5000 VAD
• MiTi Develops MitiHeart LVAD for Heart Failure Patients
• MicroMed Cardiovascular' s ' DeBakey VAD Child' Receives FDA Approval

7. Recent Industry Activity

• UPMC Wins Gold Seal of Approval(tm) to Use VADs in Destination Therapy
• E-Wilson Acquires 97% of the MicroMed Cardiovascular' s Outstanding Shares
• World Heart Enters into Partnership with Abiomed
• Thoratec Corporation Enters into Agreement with Levitronix
• World Heart Implants First Rotary VAD
• Abiomed Unveils a New Educational as well as Service Program
• MicroMed Technology Merges with Salmon Express
• Abiomed Acquires Impella CardioSystems
• Thoratec Announces 40% Increase in Medicare Refund on VADs Used in DT
• National Heart, Lung and Blood Institute Awards Contract worth $6.95 Million

8. Focus on Select Global Players

• Abiomed, Inc. (USA)
• Berlin Heart GmbH (Germany)
• EvaHeart Medical USA, Inc. (USA)
• HeartWare Limited (Australia)
• Jarvik Heart, Inc. (USA)
• MEDOS Medizentechnik AG (Germany)
• MicroMed Cardiovascular, Inc. (USA)
• SynCardia Systems, Inc. (USA)
• Terumo Heart, Inc. (USA)
• Thoratec Corporation (USA)
• Ventracor Limited (Australia)
• World Heart Corporation (USA)

9. Global Market Perspective

• Table 7: World Recent Past, Current & Future Market Analysis for Ventricular Assist Devices by Geographic Region - US, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 8: World Historic Review for Ventricular Assist Devices by Geographic Region - US, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2005 (includes corresponding Graph/Chart)
• Table 9: World 10-Year Perspective for Ventricular Assist Devices by Geographic Region - Percentage Breakdown of Dollar Sales for US, Europe, and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

III. MARKET

1. The United States

• A. Market Analysis
  • Heart Ailments - The Death Sentence
  • Table 10: Incidence, Prevalence and Deaths due to Heart Ailments in the US (2007) (includes corresponding Graph/Chart)
  • Huge Waiting Time for Heart Transplant
  • VADs for Heart Failures
  • Table 11: VAD Market in the US: Percentage Breakdown by Indication: Bridge-to-Transplant, Destination Therapy, Bridge-to-Recovery and Others (includes corresponding Graph/Chart)
  • Market Dynamics
  • High Selling Price
  • Drug Industry Poses Intense Competition
  • Lack of Timely and Quick FDA Approvals
  • Reimbursement
  • CMS Increases LVAD Coverage for Heart Patients
  • New Facility Criteria to Hospitals on VAD Implantation for Destination Therapy
  • Competition
  • Table 12: Leading Players in the US Bridge-to- Transplant VAD Market (2008E) - Percentage Breakdown of Sales for Thoratec and Others
  • Table 13: Leading Players in the US destination therapy VAD Market (2007): Percentage Breakdown of Sales for Thoratec and Others
  • Product Approvals/Innovations/Introductions
  • Strategic Corporate Developments
  • Key Players
• B. Market Analytics
  • Table 14: US Recent Past, Current & Future Analysis for Ventricular Assist Devices Market Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
  • Table 15: US Historic Review for Ventricular Assist Devices Market Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2005 (includes corresponding Graph/Chart)

2. Europe

• A. Market Analysis
  • Competitive landscape
  • Next-generation VADs in Europe by Company (2007)
  • Table 16: Heart Transplants and Patients Waiting List in Europe (2005-2007): Figures in Units (includes corresponding Graph/Chart)
  • Belgium
  • Reimbursement Scenario
  • Key Data
  • Table 17: Belgium VAD Market (2002-2005): Implants in Units (includes corresponding Graph/Chart)
  • Table 18: Belgium VAD Market (2002-2005): BTT Implants in Units (includes corresponding Graph/Chart)
  • Table 19: Belgium VAD Market (2004-2005): BTT Implants in Units by Device - Incor, Excor, Novacor, Thoratec, Medos, and TCI HM (includes corresponding Graph/Chart)
  • Germany
  • The United Kingdom
  • Product Approvals/Innovations/Introductions
  • Strategic Corporate Development
  • Key Players
• B. Market Analytics
  • Table 20: European Recent Past, Current & Future Analysis for Ventricular Assist Devices Market Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
  • Table 21: European Historic Review for Ventricular Assist Devices Market Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2005 (includes corresponding Graph/Chart)

3. Rest of World

• A. Market Analysis
  • Product Innovations/Approvals
  • Strategic Corporate Development
  • Key Players
• B. Market Analytics
  • Table 22: Rest of World Recent Past, Current & Future Analysis for Ventricular Assist Devices Market Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
  • Table 23: Rest of World Historic Review for Ventricular Assist Devices Market Independently Analyzed with Annual Sales Figures in US$ Million for Years 2001 through 2005 (includes corresponding Graph/Chart)

COMPETITIVE LANDSCAPE