Experimental artificial hearts have been around, in one form or another, for half a century. None has worked well enough to be more than a stopgap device. Now the FDA has approved the first such device for marketing (photo). It’s made by Abiomed Inc. of Danvers, Mass., for use in patients with heart failure so bad they may not live another month and who are too ill to undergo a transplant. The totally implantable pump has been tried in 14 patients (not many, as these things go) and has kept them alive for an average of five months, not counting the three who died from the surgery or never regained consciousness. In just two cases has kept recipients alive for quite a while–10 and 17 months. One of those two did well enough to be sent home.
The New York Times’s Lawrence K. Altman has a longish story, inside, with a suitably unimpressed tone. He notes that the device costs $250,000, that insurance companies may not cover the cost and, most important, he has a discussion of the fact that FDA approved the device even though it’s own advisory panel–believing the benefits did not outweigh the harms–recommended against approval.
David Brown, of the Washington Post, has a good story and encapsulated the issues in one sentence: “It also raises anew questions about how much money should be spent briefly extending the lives of critically ill patients and how to judge the cost-benefit balance of devices that are far from perfect but better than nothing.” To the quarter-million-dollar cost of the device, Brown says the implantation cost could run another $100,000. He says Medicare specifically lists artificial hearts as not covered. The L.A. Times’s Denise Gellene, however, found a source who said Medicare probably would cover the cost, after a reveiw of the data.
Laura Ungar, of the Louisville Courier-Journal, in whose town many of the hearts were implanted, discusses the rocky approval process and the stories of several patients–all men, all over six feet (it takes a large chest to contain the machinery). Most papers and Web sites used AP’s Andrew Bridges, but The Boston Globe’s Stephen Heuser staffed it.
Grist for the mill: FDA’s press release.
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