The FDA gave Humanitarian Device Exemption (HDE) approval for the AbioCor Implantable Replacement Heart (AbioCor). The approval will provide patients suffering from heart failure on both sides of their heart (bi-ventricular) and who have no other alternative a viable option for extending the quality of their life.
The AbioCor is the first completely self-contained artificial heart that may allow patients more time at home, without wires or tubes piercing through their skin. This technology provides patients with complete mobility and remote diagnostics.
The system sustains the body’s circulatory system and is designed to extend the lives of patients who would otherwise die of heart failure, while also offering a probable benefit for a satisfactory quality of life. It is able to pump blood through the body, simulating the rhythm of a heartbeat.
November 20, 2023 
