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The Artificial Heart: Prototypes, Policies, and Patients (1991)
Institute of Medicine (IOM)

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209
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The Artificial Heart: Prototypes, Policies, and Patients

heart until a suitable human heart becomes available. The patient survives 54 hours before receiving a donor heart.

1982

William DeVries implants the Jarvik-7 artificial heart into Barney Clark, a patient with end-stage cardiomyopathy, under an investigational device exemption granted by FDA that permits use of the artificial heart in patients unable to come off a heart-lung machine or in patients with chronic degenerative heart disease. Barney Clark lives 112 days.

1984/1985

The Jarvik-7 heart is implanted in four more patients, including one in Sweden.

1985

The NHLBI-sponsored Working Group on Mechanical Circulatory Support of the NHLBI publishes a report, Artificial Heart and Assist Devices: Directions, Needs, Costs, Societal and Ethical Issues. The working group endorses continued governmental support of the development of circulatory support devices, and urges NIH to resume funding to develop a totally implantable permanent heart.

1988

In January, largely on the 1985 recommendation of the working group, NHLBI awards contracts worth more than $22 million to four research groups1 to continue research and development of the TAH.

In February, responding to requests from the scientific community and others, William DeVries and colleagues publish several articles in theJournal of the American Medical Association (JAMA) that detail the medical history of each of the four total artificial heart implants that he performed.

In May, NHLBI announces that institute support for developing and integrating systems for a TAH will be suspended as of September. NHLBI Director Claude Lenfant states that the decisive factors behind the suspension of funding are that implantable LVADs are nearly ready for human testing and that NHLBI does not have sufficient funding to support both human testing of LVADs and continued development of the TAH. Dr. Lenfant notes that he was also influenced by DeVries ' JAMAarticles and by other reports of complications suffered by bridge patients who remained on the Jarvik-7 for longer than a few weeks.

1  

The four groups awarded contracts were ABIOMED, Inc., Danvers, Massachusetts; Nimbus Company, Rancho Cordova, California; Pennsylvania State University Medical Center, Hershey, Pennsylvania; and the University of Utah Institute of Biomedical Engineering, Salt Lake City, Utah.

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