Who is the AbioCor Intended for?
The AbioCor is intended for use in end-stage heart failure patients whose hearts have irreversible left and right ventricular failure and for whom surgery or medical therapy is inadequate.

In the initial clinical trial the FDA and ABIOMED have determined patients must meet the following criteria:

• Have end-stage heart failure.
• Have a life expectancy of less than 30 days.
• Not eligible for a natural heart transplant.
• Have no other viable treatment options.

How many patients could potentially benefit from the AbioCor?
More than 700,000 Americans die each year from heart failure, making it the number one cause of death in the U.S., as well as worldwide. About half of these are sudden cardiac deaths, which occur so quickly that there is not enough time for intervention with a cardiac assist or replacement device. For the remaining half, heart transplantation is one of the few options available today. Though hundreds of thousands are in need, only about 2,000 people in the U.S. will be able to receive donor hearts every year. This consistent shortage in the supply of donor hearts in the U.S. demonstrates the need for an alternative to heart transplantation. The total potential maket for the AbioCor is more than 100,000 people in the U.S. each year.

What type of patient could benefit from the AbioCor?
The AbioCor can be used with patients who suffer from congestive heart failure or coronary heart disease. Congestive heart failure, prevalent in older patients, is a result of the progressive deterioration of the heart over a number of years. Coronary artery disease is prevalent at all ages and can lead to heart attacks and chronic ischemic conditions. The AbioCor could give patients with irreversibly failing hearts an opportunity to both extend and improve the quality of their lives and return to a productive lifestyle.

What is the AbioCor made of?
The AbioCor is primarily made of titanium and Angioflex™, ABIOMED's proprietary polyether-based polyurethane plastic. Angioflex has been developed and tested by ABIOMED to be a dependable substance and safe for contact with blood. The AbioCor is designed to have relatively few moving parts. Moving parts such as the valves and hydraulic membranes are manufactured from Angioflex. Angioflex has proven flexible and durable enough to withstand beating 100,000 times a day (the approximate number of beats per day of the natural heart). The AbioCor's smooth plastic construction and unique design are specifically engineered to reduce the likelihood of damage to blood cells and to prevent clotting.

How long do the batteries last?
The internal batteries of the AbioCor offer approximately one-half hour of power, allowing patients to conduct activities, such as taking a shower, without an external power source or battery pack. External battery packs can power the AbioCor for approximately 4 hours.