NCPA - National Center for Policy Analysis


September 8, 2006

A new era in health care began Tuesday when the Food and Drug Administration (FDA) approved, on a limited basis, a battery-operated device made of titanium and plastic that is designed to permanently replace a natural heart, says the Las Vegas Sun.

Previous artificial hearts, such as the Jarvik, were designed as stop-gap devices until transplants could be performed.  Most were either much larger or performed only part of a heart's function, and they required recipients to be hooked up to an external power source at all times.

This new device, developed by Abiomed Inc. of Danvers, Mass., after decades of federally funded research, is fully implantable and allows recipients freedom of movement for periods of at least two hours.

  • About the size of a grapefruit, the device was tested from 2001 to 2004 on 14 male patients, according to the New York Times.
  • Abiomed received FDA approval to manufacture 4,000 devices a year, despite the fact that all 14 of the volunteer heart patients died.
  • Three died as a consequence of the surgery and the others survived, on average, an extra five months.

Normally such results would not qualify for FDA approval, but the device received a humanitarian exemption as recipients will be limited to those aged 18 or older who are medically ineligible for a heart transplant and whose life expectancy is one month or less.

Questions will arise about this approval, and there are a number of ethical issues.  Certainly the cost will be an issue, as each operation will exceed $250,000 and insurance companies are not likely to provide coverage.

The FDA's decision allows the device to continue to evolve by way of improvements based on outcomes.  Without the FDA approval, it might be 20 or 30 years before another device gains limited approval, says the Sun.

Source: Editorial, "Take heart in the future; New artificial heart device holds promise for patients who are nearing death," Las Vegas Sun, September 8, 2006.


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