References in periodicals archive ?
The AbioCor is intended to replace the severely damaged native heart of patients who are not eligible for a transplant and have no other treatment alternative.
The AbioCor was approved under a humanitarian device exemption.
ABIOMED initially submitted the AbioCor for marketing approval under HDE to the FDA in September 2004.
The AbioCor is a vast improvement over older fake hearts, some of which relied on 159-kg (350-lb) external power devices.
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.
This is the first AbioCor implant since the completion of clinical trials and Humanitarian Device Exemption (HDE) approval from the U.
Danvers, MA, received a Humanitarian Device Exemption (HDE) approval from the US Food and Drug Administration (FDA) for its AbioCor Implantable Replacement Heart (AbioCor).
Food and Drug Administration (FDA) will convene an expert panel of cardiovascular surgeons and cardiologists to review the groundbreaking technologies and clinical trial data behind the AbioCor artificial heart.
Unlike earlier artificial hearts, which kept patients bedridden and wired to fridge-size power sources, the new AbioCor replacement heart fits entirely in a person's chest (see diagram).
In addition to covering the AbioCor, CMS previously recommended re-aligning the payment under msDRG 1 or 2 in a draft policy document.
A US Food and Drug Administration (FDA) advisory panel narrowly rejected Abiomed, Inc's, Danvers, MA, request for a Humanitarian Device Exemption (HDE) to market its AbioCor total artificial heart.