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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. 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.
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