Ventricular Assist Devices - Global Trends

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Ventricular Assist Devices - Global Trends

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Globally, about one million people suffer from end-stage heart failure. With demand for heart transplantation, the traditional procedure for end-stage heart failure, surpassing the availability of donor hearts, use of ventricular assist devices (VADs) has emerged as an ideal alternative form of treatment for such patients. Development of VADs with improved design, features and durability is expected to expand its adoption across a broader patient population, including women and children.

Besides, the arrival of second generation and third generation VADs has expanded the scope of using destination therapy as an early intervention measure in the treatment of heart failure, thereby offering hope to several heart failure patients. Destination Therapy holds vast potential in the overall ventricular assist devices (VAD) market, driven primarily by the benefits of procedure when compared to conventional heart transplantations. Further, the procedure holds promise owing to its use among patients who are otherwise ineligible for donor hearts due to old age or severe sickness.

These and other market data and trends are presented in "Ventricular Assist Devices: Global Trends" by BizAcumen, Inc. Our reports are designed to be most comprehensive in geographic coverage and vertical market analyses.

VENTRICULAR ASSIST DEVICES BMR-1053

CONTENTS

1. METHODOLOGY 1

Study Reliability and Reporting Limitations 1

Disclaimers 2

Quantitative Techniques & Reporting Level 3

2. INTRODUCTION 4

Opportunities in VAD Market 4

Destination Therapy - An Immense Potential Opportunity 4

Next Generation Devices to Offer Pronounced Scope 5

Heart Transplantation Scenario 5

3. COMPETITION 6

Thoratec is the Clear Leader 6

Leading Players in the Global VAD Market 6

Competition Heats Up 7

Competitive Technologies 7

4. PRODUCT FACTS 8

VADs 8

Reimbursement Scenario 8

Select First, Second and Third Generation Implantable VADs (

2008) 9

5. CORPORATE DEVELOPMENTS 10

UPMC Wins Gold Seal of Approval™ to Use VADs in Destination

Therapy 10

E-Wilson Acquires 97% of the MicroMed Cardiovascular's

Outstanding Shares 10

Thoratec Receives FDA Approval for its HeartMate II LVAS 10

HeartWare Receives Conditional Approval for its HeartWare LVAS 10

Abiomed Receives CE Mark for AB5000 Portable Driver 10

World Heart Enters into Partnership with Abiomed 11

Ventracor Receives USFDA Approval to Use its VentrAssist

Device in Clinical Trials 12

NewCorTec Launches a New LVAD 12

WorldHeart Launches New Pediatric VAD 12

Ventracor Obtains FDA Approval for VentrAssist's US BTT Trial 12

MicroMed Cardiovascular Obtains 5-Year CE Mark Extension for

DeBakey 12

Thoratec Submits PMA for HeartMate II Left Ventricular Assist

System 13

Ventracor Receives 'Commercial Ready' Grant to Develop

VentrAssist LVAD 13

Terumo Heart Obtains CE Mark for its DuraHeart® LVAS in Europe 13

Abiomed Acquires Regulatory Approval in Australia for Impella

LP 2.5 LVAD 13

6. MAJOR PLAYERS 14

Abiomed, Inc. (USA) 14

Berlin Heart GmbH (Germany) 14

EvaHeart Medical USA, Inc. (USA) 14

HeartWare Limited (Australia) 14

Jarvik Heart, Inc. (USA) 14

MEDOS Medizentechnik AG (Germany) 14

MicroMed Cardiovascular, Inc. (USA) 15

SynCardia Systems, Inc. (USA) 15

Terumo Heart, Inc. (USA) 15

Thoratec Corporation (USA) 15

Ventracor Limited (Australia) 15

World Heart Corporation (USA) 16

7. GLOBAL MARKET ANALYTICS 16

8. THE UNITED STATES 17

Heart Ailments - The Death Sentence 17

Huge Waiting Time for Heart Transplant 17

VADs for Heart Failures 17

Market Dynamics 18

High Selling Price 18

Drug Industry Poses Competition 18

Lack of Timely and Quick FDA Approvals 18

Reimbursement 19

CMS Increases LVAD Coverage for Heart Patients 19

New Facility Criteria to Hospitals on VAD Implantation for

Destination Therapy 20

Competition 20

9. EUROPE 21

Competitive Landscape 21

Belgium 22

Reimbursement Scenario 22

Germany 22

The United Kingdom 22

10. REST OF WORLD 23

EXHIBITS

Table 1: Percentage Share Breakdown of Heart Transplants by

Country/Region in the World - 2008E

Table 2: Percentage Breakdown of Leading Players in the Global

VAD and Circulatory Support Market - 2007

Table 3: Implantations in Units by Select Players in the

Global VAD Market - 2007

Table 4: Average Selling Prices of Select VADs by Company and

Model

Table 5: Global Ventricular Assist Devices Market by Region

for the Period 2007-2015 (Sales in US$ Million)

Table 6: Percentage Breakdown of Global Ventricular Assist

Devices Market by Region for the Years 2008 & 2012

Table 7: VAD Market in the US: Percentage Breakdown by

Indication

Table 8: Ventricular Assist Devices Market by Segment in the

US: 2007-2015 (Sales in US$ Million)

Table 9: Ventricular Assist Devices Market by Segment in

Europe: 2007-2015 (Sales in US$ Million)

Table 10: Ventricular Assist Devices Market by Segment in

Rest of World: 2007-2015 (Sales in US$ Million)

COMPANIES PROFILED

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