Abiomed has announced that it has received permission from the US Food and Drug Administration (FDA) to begin the initial clinical trial of its AbioCo Replacement Heart.
The AbioCor Implantable Replacement Heart is reported to be a fully implantable prosthetic system intended as a substitute for severely diseased human hearts in patients suffering from coronary heart disease or some form of end-stage congestive heart failure.
After implantation, the device does not require any tubes or wires to pass through the skin, whilst power to drive the prosthetic heart is transmitted across the intact skin, avoiding skin penetration.
The AbioCor Implantable Replacement Heart is said to operate like a normal heart as it consists of two blood-pumping chambers: the right pump supplies blood to the lungs, while the left pump provides blood to other vital organs and the rest of the body.
Each of the two pumps, made from Angioflex, a proprietary ABIOMED material, is said to be capable of delivering more than two gallons of blood every minute.
An internal controller regulates power delivered to the prosthetic heart.
Without penetrating the skin, an external unit transmits power to the internal unit. A rechargeable internal battery allows the patient to be completely free of the external power transmission unit for some period of time.
The AbioCor system is designed to increase or decrease its pump rate in response to the body’s needs and includes an active monitoring system that provides performance feedback and alarms in the event of irregularities.