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Research Sponsored by NHLBI Results in FDA Approval
of Permanent Artificial Heart
Brief Description:
The US Food and Drug Administration has approved the first totally implanted
artifical heart for patients with advanced heart failure in both of
the heart's pumping chambers.
Transcript:
SCHMALFELDT: The US Food and Drug Administration has
approved the first totally implanted artifical heart for patients with
advanced heart failure in both of the heart's pumping chambers. The National
Heart, Lung and Blood Institute at the National Institutes of Health
supported the research which led to the development of the device, which
is intended for patients who are not eligible for a heart transplant
and whose life expectancy without the device is only a month. Doctor
Daniel Schultz, director of the FDA's Center for Devices and Radiological
Health announced the approval during a recent teleconference.
SCHULTZ: Today's approval represents a significant
step in the evolution of this important technology, allowing it to come
to the marketplace in a way that we feel best serves the needs of the
American public. We hope that today's approval will encourage the continued
development and refinement of this technology, and in fact we know that
investigators are continuing to work on these products and that further
refinements will make this product safer and more effective in the future,
and hopefully allow it to be used earlier on in the process of heart
failure for larger populations.
SCHMALFELDT: Since the 1960s, the NHLBI has funded
extensive basic research to develop a range of mechanical heart support
devices, including the total artificial heart and ventricular assist
devices. About five million people in the United States suffer from heart
failure, and it contributes to or causes about 300-thousand deaths per
year. From the National Institutes of Health, I'm Bill Schmalfeldt in
Bethesda, Maryland.
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| Date: 09/08/2006 |
Reporter:
Bill Schmalfeldt |
Sound
Bite:
Dr. Daniel Schultz |
Topic:
Heart Disease
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| Institute(s): NHLBI |
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