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. Pre-operative non-invasive anatomical assessment is performed for thoracic volume fitting of the AbioCor. Patients should not have severe coagulation disorders.

The AbioCor® is indicated for use in severe biventricular end stage heart disease patients who are not cardiac transplant candidates and who:

• are less than 75 years old,
• require multiple inotropic support,
• are not treatable by LVAD destination therapy, and
• are not weanable from biventricular support if on such support.