AbioCor Implantable Replacement Heart

Inclusion Criteria:

- Patients in severe biventricular end stage heart disease who are not cardiac
transplant candidates and who are adults 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.

Exclusion Criteria:

- Patients with other irreversible end organ dysfunctions that would compromise
survival, having in clinical assessment a more than 30% chance of survival beyond 30
days, inadequate psychosocial support, or patients in whom fit is a problem, based on
preoperative noninvasive anatomical assessment showing that the thoracic volume is
unable to accommodate the device.