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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Some of the notable devices approved by the agency since 2006 include Abiomed's AbioCor implantable replacement heart, Smith & Nephew's Birmingham hip resurfacing system, new drug-eluting stents from Medtronic and Abbott, and Infuse bone graft from Medtronic Sofamor Danek.
Danvers, MA, received a Humanitarian Device Exemption (HDE) approval from the US Food and Drug Administration (FDA) for its AbioCor Implantable Replacement Heart (AbioCor).
The AbioCor Implantable Replacement Heart is the first fully implantable artificial heart for severe end-stage heart failure patients who are younger than 75 years, not transplant candidates at the time of assessment, and in biventricular failure not treatable by a destination-therapy left ventricular--assist device.
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.
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.
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).
Danvers, MA, announced it has reached a collaborative agreement with the Rabin Medical Center, Petach-Tikva, Israel, with the objective of demonstrating device the team readiness of ABIOMED's AbioCor Implantable Replacement Heart in preparation for human trials.
Nasdaq:ABMD) as the recipient of the 2004 Technology Leadership Award for developing innovative circulatory assist devices (CAD) including the BVS and AB5000 Circulatory Support Systems and the AbioCor Implantable Replacement Heart.
The AbioCor Implantable Replacement Heart is designed not only to extend the lives of patients who would otherwise die of heart failure, but also to offer a satisfactory quality of life.