AbioCor Implantable Replacement Heart

AbioCor Implantable Replacement Heart

A fully implantable device which is intended to extend life and improve the quality of life in patients with coronary heart disease or end-stage congestive heart failure who are at a high risk of death. The power for the device is transmitted across intact skin; post-implantation, no tubes or wires pass through skin, reducing the risk of infection.
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This News Release contains forward-looking statements, including statements regarding development and timing of the AbioCor implantable replacement heart program, other product development and regulatory efforts for new products such as the AB 5000 console, and anticipated revenue growth.
The Company's AbioCor Implantable Replacement Heart is being implanted in patients as part of an initial clinical trial conducted under an Investigational Device Exemption from the United States Food and Drug Administration.
Danvers, MA, received a Humanitarian Device Exemption (HDE) approval from the US Food and Drug Administration (FDA) for its AbioCor Implantable Replacement Heart (AbioCor).
today announced that the company has submitted, pending acceptance for filing, to the Food and Drug Administration for market approval of the AbioCor Implantable Replacement Heart under a Humanitarian Device Exemption (HDE).
the manufacturer of the AbioCor implantable replacement heart.
Food and Drug Administration, requesting approval to commence initial human trials of its AbioCor Implantable Replacement Heart.
The AbioCor Implantable Replacement Heart is one of the most sophisticated medical devices ever developed and is designed to extend the lives of patients who would otherwise die of heart failure.
The AB5000 is ABIOMED's newest product offering, based on technology developed for the AbioCor Implantable Replacement Heart and approved by the FDA in 2003.
Abiomed, the maker of the AbioCor Implantable Replacement Heart that was implanted in Quinn, said in a statement: "ABIOMED is very disappointed to learn that Mrs.
The AbioCor Implantable Replacement Heart, made by Abiomed, was approved for use yesterday by the U.
Tom Christerson, the second person in the world to receive the AbioCor Implantable Replacement Heart, released the following statement:
The AbioCor Implantable Replacement Heart is being implanted in patients as part of an initial clinical trial conducted under an Investigational Device Exemption from the US Food and Drug Administration (FDA).