Abiomed Implantable Heart Device Receives F.D.A. Approval
The New York Times reports that on Tuesday, Abiomed received FDA approval to sell the world's first fully implantable mechanical heart. The company received a "humanitarian device exemption" since the device demonstrated "safety and probable benefit." Normally to be approved by the FDA, devices must demonstrate "safety and effectiveness," which an expert panel convened earlier this year argued that the Abiomed device failed to demonstrate.
Many congestive heart failure (CHF) patients die waiting for their heart transplant, and this device, with all of its failings, could be a last hope for these patients. It's very exciting to consider that up to 4,000 CHF patients a year, above the age of 18, with less than a month of life expectancy left, will have this as option to give them a few extra months of hope that they could receive a heart transplant.
Past artificial hearts required a patient to be continually attached to equipment that powered and supported the device. The Abiomed device provides an internal battery to allow a patient an hour of disconnected use, and 2 external batteries that allow 2 hours of freedom.
There are many limitations, including the need for a patient be able to tolerate blood thinning medicines to prevent blood clots, as well as have a large enough chest cavity to hold the device. Even with the limitations, hopes are that more experience with this device will provide important research to develop improved mechanical hearts that are available for use by less severely ill patients, and eventually for permanent implantation.
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"In the opinion of most health policy experts, that is not a cost-effective use of resources," said Sean D. Sullivan, director of the Pharmaceutical Outcomes Research and Policy Program at the University of Washington. "Most cancer biologics [biotech drugs] that extend life by four to five months are about one-third or one-quarter the cost of this artificial heart."
MedGadget & update.
The editors of the American Journal of Bioethics express caution.
Sci-Tech Today gets the story wrong: they state "it is likely the last heart they'll have" although this device is intended to be a bridge device until a transplant is available.
KevinMD: "It just doesn't fit in most people"
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