FDA Approval of First Totally Implanted Permanent Artificial
Heart -- Statements from
National Heart, Lung, and Blood Institute Director Elizabeth, G.
Nabel, M.D. and National Institutes of Health Director Elias A.
Zerhouni, M.D.
Dr. Nabel:
Today the U.S. Food and Drug Administration approved the first totally
implanted artificial heart for patients with advanced heart failure
in both of the heart’s pumping chambers. The device is intended
for patients who are not eligible for a heart transplant and whose
life expectancy without the device is only a month. Heart failure
is a serious condition in which the heart is unable to pump enough
blood throughout the body. About 5 million people in the United
States have heart failure and it contributes to or causes about
300,000 deaths every year.
The approval of the totally implanted artificial heart is a significant
milestone as there are few options for heart failure patients with
the most severe form of the disease and who are in critical need.
The National Heart, Lung, and Blood Institute (NHLBI) of the National
Institutes of Health is proud to have supported the research which
led to this development. Since the 1960s, NHLBI has funded extensive
basic research to develop a range of mechanical heart support devices,
including the total artificial heart and ventricular assist devices
(VADs). This research has led to the development of the devices
in use today, which are smaller, more durable, and biocompatible
than early models. Among the key clinical studies conducted was
an NHLBI-supported trial of left ventricular assist devices in patients
with end stage-heart failure (Randomized Evaluation of Mechanical
Assistance for the Treatment of Congestive Heart Failure or REMATCH).
REMATCH was an important step along the way toward the development
of the total artificial heart – providing data on both the
benefits and problems associated with long term mechanical support.
The totally implanted artificial heart is the culmination of years
of research and testing to establish reliability, performance, and
safety. It has been the life’s work of teams of scientists,
engineers, and designers. And now for the patients who qualify for
this device, it can mean longer life – and a better quality
of life.
Dr. Zerhouni:
For over half a century, scientists and engineers have dreamed of
a total artificial heart. The National Heart, Lung, and Blood Institute’s
long-term commitment to this technology has helped to make this
dream a reality. It is a shining example of an NIH institute supporting
the development of a medical device that has great public impact
– from basic research through preclinical testing and on to
clinical readiness. The total artificial heart will extend and improve
the quality of life for patients who have no other treatment option.
This accomplishment also demonstrates the kind of long term interdisciplinary
scientific efforts needed to address increasingly complex health
challenges that often seem initially insurmountable to many. This
could not have happened without the patient and far sighted leadership
of NHLBI and NIH over several decades.
Part of the National Institutes of Health, the National Heart,
Lung, and Blood Institute (NHLBI) plans, conducts, and supports
research related to the causes, prevention, diagnosis, and treatment
of heart, blood vessel, lung, and blood diseases; and sleep disorders.
The Institute also administers national health education campaigns
on women and heart disease, healthy weight for children, and other
topics. NHLBI press releases and other materials are available online
at: www.nhlbi.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and Centers
and is a component of the U. S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting basic,
clinical, and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases.
For more information about NIH and its programs, visit www.nih.gov.
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