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 an 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 also accomplishment 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.
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. |