Heart failure (HF) occurs when oxygenated blood is not fully cleared from the lungs, inhibiting blood flow to the rest of the body. Once a patient starts down the path of heart failure, the underlying disease causes the condition to actually accelerate. Moreover, many symptoms associated with HF can be treated, but often the underlying functional impairment of the heart cannot. As a result of blood not being cleared fully, the left ventricle tries to pump additional blood and becomes overworked causing the left ventricle to expand and the heart to become more constricted, further preventing adequate blood flow.

Heart transplantation, currently, is the only curative treatment option which ultimately provides the best recovery of cardiac function. This treatment option has severe limitations, one due to limited availability of donor hearts and secondly, ineligibility of many patients for transplantation due to many factors. Drug treatment and pacing devices also do not halt the progression of the disease. Other devices and cell based therapy are either in the early stages of development or are otherwise not achieving the desired results. Due to these factors, VADs are gaining increasing clinical recognition as a viable long term treatment option.

The population of those suffering from diagnosed congestive heart failure has been increasing while the number of donor hearts available are on a decrease, implying good growth prospects for left ventricular assist devices (LVAD) market. The main application of LVAD is currently for the Bridge-to-Transplant (BTT) market and not so much under the Destination Therapy (DT) market, However, DT application is expected to gain penetration in the near future as efforts are currently on to gain FDA approval for DT application of LVADs for the DT market. Bridge-to-Decision (BTD), which is not a formal indication established by the FDA, would also open new growth avenues for LVADs.

The report provides an overview of the heart failure and its treatments options and LVAD as one of the options. The market size and growth in the LVAD market is explained in details, along with the associated end stage heart failure cost and LVAD reimbursement. The growth drivers and challenges are also discussed. The key players are profiled with their strategies for the market and the competition among the players is also discussed in detail.

1. Overview

1.1 Heart Failure (HF)

Heart Failure as a disease and its implications
Heart Failure stages and mortality rates within those respective stages

1.2 Current Treatment Options for Heart Failure

Various treatment options for heart failure
Treatment options for different stages of heart failure
Use of LVADs for BTT and DT indications

2. Market Size

Increasing heart failure cases – heart failure a leading cause of death globally
Global LVAD market growth – BTT and DT markets
US and OUS BTT and DT market growth
Heart failure cases in Asian region
BTT and DT market penetration
US LVAD market growth projection on the basis of target population

3. Cost and Reimbursement in LVAD Market

Developments in medical therapy costs over past years
LVAD Reimbursement developments over the past years

4. LVAD Market Dynamics

4.1 Growth Drivers

4.1.1 Under-Penetrated Market
4.1.2 Growing Patient List and Limited Donor Hearts Available
4.1.3 Expected Growth in DT Application
4.1.4 Increasing Referrals
4.1.5 Bridge-to-decision (BTD) guidelines
4.1.6 Expansion in the number of LVAD centers

4.2 Barriers for DT adoption

4.2.1 Geographic Limitations
4.2.2 Physician Education

5. Competition in LVAD Market

Key competitive factors for the industry players
Sales and market share growth of key players
Clinical trials by different players
VADs currently in development stages and BTT product launches

6. Company Profiles

6.1 Thoratec Corporation

Business Overview
Business Strategies
Partnership with Leading Heart Centers
Greater use of VADs in existing segments
Increase presence in Cardiovascular and ITC segments

6.2 HeartWare International, Inc.

Business Overview
Business Strategies
Commercially launch the HeartWare System in Europe and Australia
Obtain regulatory approval in the United States
Continue sales and marketing activities
Focus on continuous product development

6.3 WorldHeart Corporation (USA)

Business Overview
Business Strategies
Consolidation Plan
Marketing, Manufacturing and Distribution Strategy

6.4 Abiomed, Inc.

Business Overview
Business Strategies
Global distribution and clinical expertise in the cath lab
Establish recovery awareness through clinical data and published scientific studies
Enhance the product portfolio

List of Tables

NYHA Classification of Heart Failure
Global LVAD Application (BTT & DT) Market Growth (2007A-2013E)
US and Outside US BTT Market Growth (2007A-2013E)
US and Outside US DT Market Opportunity (2007A-2013E)
US LVAD Market Opportunity (2007A-2012E)
CPT Codes for VAD Implantation
US Sales & Market Share of Major Players (2007-2010E)
US VAD Market Share Growth (2007A-2010E) (Part 1)
US VAD Market Share Growth (2011E-2015E) (Part 2)
Outside US Sales & Market Share of Major Players (2007-2013E)
Worldwide Sales & Market Share of Major Players (2007-2013E)
BTT Product Launches

List of Charts

Mortality Rates of Various HF Classes
Stages of HF and associated interventions
Breakdown of HF Market (2008)
Diagnosed Congestive Heart Failure Population (2007A-2015E)
Global LVAD Market Growth Estimates (2008A-2013E)
BTT Market Penetration Estimates (2007A-2013E)
DT Market Penetration Estimates (2007A-2013E)
Medical Therapy Costs over last 2 years for End-Stage HF Patients
LVAD Reimbursement Trend (2002-2009)
Sales Growth of Thoratec Corporation (2004-2008)
Sales Growth of HeartWare International, Inc. (2006-2008)
Sales Growth of WorldHeart Corporation (USA) (2004-2008)
Sales Growth of Abiomed, Inc. (2005-2009)