U.S. Market for Cardiovascular Devices, The

This report considers the markets for therapeutic cardiovascular devices, such as prosthetic valves, pacemakers, stents, support devices, ICDs, VADs, and TAHs, in the United States as broken down into four major segments:

cardiomyopathy/congestive heart failure

arrhythmias

arteriosclerosis (coronary artery disease), and

valvular heart disease

While there are other cardiovascular conditions that remain significant in the American population, e.g., stroke and myocardial infarction, these four conditions present the core conditions that lead to more serious cardiovascular accidents and death and present the opportunity for the therapeutic device market.

This report discusses the market for specific therapeutic device products for the cardiovascular market in terms of their potential in the population in the United States as a whole and in the 45-years-old and older subsegment of the U.S. population through 2014. Market potential is used as opposed to a rehash of experienced and projected revenues for several reason for this:

A large number of therapeutic applications for cardiovascular disease are currently in development and are based on advanced technology in therapeutic device design and development.

Because much of the potential use of new therapeutics is not associated with commonly available databases, it is often impossible to determine their level and type of their application in the growing market environments.

The status of the current market in terms of revenues is misleading of the potential market as a whole. It does not allow for the understanding of the potential of unmet need, which will be discussed in the various sections of this report, and is in no way reflected by the current revenue picture for therapeutic cardiovascular devices.

As a result, we believe these market assessments provide a more realistic view of the opportunities available to those who are engaged or interested in addressing them. The key is in understanding how much of this potential has actually been realized and how much is unmet need.

The analysis presented in this report is based on data from a combination of company, government, industrial, institutional and private sources. It includes information from extensive literature reviews, as well as interviews and discussions with experts in the field, including experts in cardiology, cardiac surgery, vascular surgery, internal medicine, and gerontology, as well as research scientists, and business development and marketing managers within the medical devices, industries. The analyses are based on:

The current and expected levels of research and development for age-related cardiovascular disease therapeutic devices

The general trends in population demographics; epidemiology of cardiomyopathy/congestive heart failure, arrhythmia, arteriosclerosis, and valvular heart disease; and other factors that affect those trends

The trends in approaches to cardiovascular disease prevention

Costs analysis based on studies of actual research and projected costs of new cardiovascular disease therapeutic products by those engaged in their development.

September 1, 2005

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