Here’s an interesting additional point on the story of Abiomed’s AbioCor total artificial heart that has been approved with a humanitarian device exemption for use in a limited patient population with only a few months to live. This new population represents as many as 4000 patients in the US, as opposed to their last group of 14. From the WaPo article:
The device would be limited to people with severe congestive heart failure who are estimated to have about a month to live and do not qualify for heart transplants. Those patients must also be able to take anticoagulant drugs.
Because of its size — about two pounds — only large women would be able to accommodate it. All the original recipients were men.
“Just being able to ambulate, to clearly communicate with loved ones, and to celebrate family events is in the view of many patients and family members a significant improvement in quality of life,” said Bram D. Zuckerman, director of the FDA’s office of cardiovascular devices.
“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.”
Ah yes, the cost:benefit problem. Seems like the question for biomedical engineers no longer lies with solving an unsolvable medical problem, but with doing so in a cost effective manner.
More from the Washington Post…