The Artificial Heart Goes Private

In 1976, Willem Kolff (a physician and the inventor of kidney dialysis and one of the first artificial hearts) and some of his Utah colleagues formed a private company, Kolff Medical Associates, to attract venture capital to support their research. In order to interest private investors, they had to create a marketing program for their mechanical heart. The decision to proceed with a private company constituted a first step into the emerging and often ethically controversial world of public-private partnerships intended to advance medical research.

After further testing and redesign of models previously tested in calves, Clifford Kwan-Gett, Willem Kolff, and later Robert Jarvik managed to use a Jarvik-7 to keep some animals alive for as long as eight months. In 1980, Kolff Medical Associates applied for permission from the institutional review board (IRB) of the University of Utah Medical Center to try the device on a human being. They also sought permission from the U.S. Food and Drug Administration (FDA), which, since 1976, had authority to regulate the testing and marketing of medical devices. While awaiting approval, members of the Utah artificial heart group traveled to Philadelphia and conducted a series of three practice implants of a Jarvik-7 heart on brain-dead patients at Temple University Medical Center. Permission from family members to use the cadavers was obtained by Jack Kolff, Willem Kolff's son, then a surgeon at Temple.

After many weeks of resubmissions and revisions, the IRB at Utah and the FDA granted approval to undertake a series of seven implants of a Jarvik-7 heart in human beings at the University of Utah. The subjects were to be patients with very severe, life-threatening congestive heart failure resulting from cardiomyopathy, a poorly understood condition that causes irreversible fatal damage to the muscle of the heart (Scherr et. al.). Kolff and Jarvik, who had renamed their company Symbion, selected a young surgeon, William DeVries, to perform the first implant in a human recipient.

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