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AbioCor System is designed for use by patients who have irreparably
damaged hearts or who are at risk of imminent death as a result of
end-stage heart failure that cannot be treated by optimal medical
treatment. Patients who are candidates for the AbioCor System have
biventricular failure but typically have other vital organs that continue
to be viable or are potentially recoverable.
The AbioCor Implantable Replacement Heart System is indicated for
patients who may benefit from heart replacement and who do not meet
the criteria for receiving a left ventricular assist device (LVAD),
or patients who are not likely to benefit from (or may encounter
unacceptably high risks of complications or harm from) long-term
assist with an LVAD or other device. Included in this group are
persons with the following conditions:
- severe right ventricular failure, in addition to severe left
ventricular failure
- pulmonary hypertension refractory to pharmacologic management
- significant aortic valve regurgitation
- mechanical valve prosthesis
- intractable life-threatening arrhythmias
- massive acute myocardial infarction with friable tissue
- ventricular septal rupture
- failed heart transplant (rejection) with immunosuppression
- thrombus in the ventricles
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