Frequently Asked Questions (FAQ)

What is the AbioCor?

The AbioCor™ Implantable Replacement Heart is an advanced medical system being developed by ABIOMED Inc., in order to extend and improve the lives of patients who would otherwise die of heart failure. The AbioCor, designed to fully sustain the body's circulatory system, is intended to serve as an alternative to heart transplantation -- the current method of saving patients with failing natural hearts.

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. ABIOMED believes that currently more than 100,000 people in the U.S. could benefit from the AbioCor each year.

What type of patient could benefit from the AbioCor?

The AbioCor is intended for use with patients whose hearts have irreparably damaged left and/or right ventricles, and for whom existing methods of surgical intervention and/or drug therapy are inadequate. 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.

Today, those end-stage heart failure patients in theh U.S. who are not fortunate to receive one of the limited 2,000 donor hearts have no alternative but to face death. The AbioCor could give these patients with irreversibly failing hearts an opportunity to both extend and improve the quality of their lives and return to a productive lifestyle. A similar need exists throughout the world.

How does the AbioCor work?

As one of the most sophisticated implantable medical devices to be developed, the AbioCor is designed so that a patient can remain mobile and continue a productive lifestyle. Equipped with an internal motor, the AbioCor is able to move blood through the lungs and to the rest of the body, simulating the rhythm of a heartbeat. The AbioCor consists of an internal thoracic unit, an internal rechargeable battery, an internal miniaturized electronics package and an external battery pack.

The thoracic unit, weighing about two pounds, includes two artificial ventricles with their corresponding valves and a motor-driven hydraulic pumping system. The implantable electronics package monitors and controls the pumping speed of the heart based on the physiologic needs of the patient. The AbioCor operates on both internal and external lithium batteries. The internally implanted battery is continually recharged from an external console or from a basic patient-carried external battery pack. This is achieved with an energy transfer device called TET (transcutaneous energy transmission). The TET system consists of a set of coils, one internal and one external, which transmit power across the skin without piercing the surface.

How long do the batteries last?

The internal batteries of the AbioCor are sized for a one-half hour operation at implant, allowing patients to conduct activities, such as taking a shower, without an external power source or battery pack. External battery packs can be used for many hours depending on the number of battery packs carried.

What is the AbioCor made of?

The AbioCor is primarily made of titanium and Angioflex(TM), 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.