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

 

 
The 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

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