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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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