Abiomed Inc. has announced it received approval on January 30 from the Food and Drug Administration to test AbioCor, the world's first implantable artificial heart, in five patients.
The grapefruit-size, battery-powered heart is intended for use in patients with endstage heart failure who are at risk of imminent death, are not candidates for heart transplantation, and cannot be helped by other therapies.
The investigational device exemption granted by the FDA allows the AbioCor to be implanted in five patients. (Abiomed asked for the IDE in December; see Transplant News Network, January 1, 2001, "Abiomed Wants to Test Implantable Replacement Heart in Humans".) The first implant is expected to take place in the next few months. Clinical trial centers include Brigham and Women's Hospital with Massachusetts General Hospital, Boston; Hahnemann University Hospital, Philadelphia; Jewish Heart and Lung Hospital, Louisville, Kentucky; Texas Heart Institute, Houston; and UCLA Medical Center, Los Angeles.
AbioCor is a fully implantable system. An internal battery that regulates the power delivered to the prosthetic heart is continually recharged by an external power source designed to be worn around the patient's waist. The power is transmitted transcutaneously, and no tubes or wires pass through the skin after implantation.
Like the natural heart, AbioCor consists of two blood-pumping chambers, each of which can deliver more than two gallons of blood every minute.
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