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What is the AbioCor Replacement Heart?
Who is the AbioCor for?
Indications
 

 

 

The AbioCor is intended for use in patients with irreversibly failing hearts who cannot benefit from existing treatment methods, such as surgical intervention, drug therapy, or other approved devices.

The most common conditions leading to the failure of your heart include congestive heart failure (CHF) and coronary heart disease (CHD). Congestive heart failure, prevalent in older patients, is a result of the progressive deterioration of the heart over many years. Coronary heart disease is prevalent at all ages and can lead to heart attacks and chronic conditions in which the heart muscle is damaged due to lack of adequate oxygenation.

The AbioCor is currently an experimental device that can only be offered to patients who are extremely ill and who wish to enroll in a clinical trial in the USA. ABIOMED has applied with the FDA for commercial approval under a Humanitarian Device Exemption, which would make the AbioCor available to up to 4,000 patients with end-stage heart failure each year in the US.

The AbioCor is not CE certified and is not available in Europe at this time.