FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: AbioCor® Implantable Replacement Heart
Manufacturer: Abiomed, Inc.
Address: 22 Cherry Hill Drive, Danvers, MA 09123
Approval Date: September 5, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040006a.pdf
What is it? The AbioCor is an electrically powered pump (pulsatile electrohydraulic device) used to replace the main pumping chambers (the ventricles) of the human heart. It can deliver up to 8 liters of blood per minute over a broad range of blood pressures. The device consists of a “Thoracic Unit” containing two sealed blood pumps, separated by an energy converter. The Thoracic Unit is connected to the heart’s two upper collecting chambers (the atria) and the two major outgoing vessels supplying blood to the lungs and to the rest of the body. (The heart’s lower pumping chambers, the ventricles, have been removed). The energy converter moves hydraulic fluid from one side of the device to the other, squeezing a sac containing the blood in one side of the pump to force the blood through the connected outgoing vessel. Simultaneously, blood is actively drawn into the pump on the opposite side, filling it for the next cycle, which will discharge blood to the other outgoing vessel.
How does it work? The AbioCor is designed to duplicate the function of the normal heart by circulating blood through the body and the lungs. An implanted controller regulates and monitors the Thoracic Unit. The controller can receive and transmit information by way of radio communication to a system that is external (not connected) to the body, There is also an implanted battery that can operate the implanted system in the absence of the external power source, thereby allowing the patient to be free from all external connections.
A coil implanted under the skin can receive energy (by induction) from an external power source to recharge the implanted battery. An external controlling device allows one to monitor the status of the implantable system and also can alter the system’s operating conditions.
When is it used? The AbioCor is indicated for use in patients who:
- have both major pumping heart chambers (the ventricles) that are failing
- have end-stage heart disease
- are not transplant candidates
- are less than 75 years old
- are not treatable by single left ventricular heart assist devices for destination therapy
- are not able to be withdrawn from heart support measures
What will it accomplish? The AbioCor may provide circulatory support to patients with severe heart failure. Moreover, the device may have the ability to restore normal flow of blood and blood pressures and restore organ function (e.g. kidneys and liver) in patients who are not heart transplant candidates.
When should it not be used? The AbioCor should not be used in patients who are eligible for a heart transplant, in patients where the device will not fit, in patients who cannot be successfully treated for blood clotting disorders or who have only left sided heart failure.