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FDA Approves First Artificial Heart to Keep People
Alive Until Transplant Available
 Oct.
19, 2004 - The Food and Drug Administration (FDA) yesterday announced
approval of a partial artificial heart intended to keep people alive in
the hospital while they are awaiting a heart transplant.
The CardioWest Temporary Total Artificial Heart is the first
FDA-approved temporary total artificial heart.
The product is a pulsating bi-ventricular device
that is implanted into the chest to replace the patient's left and right
ventricles (the bottom half of the heart). The implanted device is sewn
to the patient's remaining atria (the top half of the heart).
Hospitalized patients are connected by tubes from the heart through
their chest wall to a large power-generating console, which operates and
monitors the device.
The heart is manufactured by Syncardia Systems
Inc., of Tucson, Ariz. It is intended as a "bridge to transplant" for
people waiting for a heart transplant who do not respond to other
treatments and are at risk of imminent death from non-reversible
bi-ventricular failure, i.e. people with both left and right side heart
failure, and who are eligible for a heart transplant.
The CardioWest completely replaces the patient's diseased heart and
immediately restores normal blood pressure and cardiac output,
facilitating recovery of end-organ function, such as the kidney and
liver. As a result, patients become better candidates for
transplantation.
"The FDA's approval of the first temporary total artificial heart
represents a significant milestone in medical history. With the
CardioWest TAH-t, we will be able to save the lives of many critically
ill patients who are in need of or who are awaiting heart transplants.
The CardioWest TAH-t fills an unmet medical need, and we are thrilled to
offer this device to cardiac surgeons and cardiologists at heart
transplant centers nationwide," said Dr. Marvin J. Slepian, president
and CEO, SynCardia Systems.
FDA approved the Syncardia device based on a review
of clinical studies of safety and effectiveness conducted by the firm
and on the recommendation of an outside panel of experts convened by FDA
to review the device.
"Over nine years ago, we began collecting research and data on the
efficacy of the CardioWest Temporary Total Artificial Heart and today's
approval from the FDA represents the culmination of our efforts," said
Dr. Jack G. Copeland, Chief, Section of Cardiovascular and Thoracic
Surgery, University of Arizona Sarver Heart Center. "This is a
tremendous day not only for SynCardia but for all people and their
families affected by non-reversible biventricular failure."
The firm studied use of the artificial heart in 81
transplant-eligible patients with severe bi-ventricular heart failure at
five medical centers in the United States. In the studies, 79 percent of
patients implanted with the heart remained alive long enough to receive
a donor heart (an average of 79 days), demonstrating that the artificial
heart could successfully serve as a bridge to transplant.
Complications included infection (72% of patients),
bleeding (42%), neurological event such as major or minor stroke (25%)
and device malfunctions (18%). Seventeen patients in the study died
before a donor heart became available.
About 4,000 patients in the United States await
heart transplants annually. Only about 2,200 donor hearts typically
become available. About 100 of the 4,000 patients awaiting transplants
have non-reversible bi-ventricular failure and could be candidates for
the new artificial heart.
FDA is requiring the firm to conduct a
post-approval study to monitor the device's performance in commercial
use.
About the CardioWest Temporary Total Artificial Heart
The CardioWest&trade TAH-t is a pneumatic, biventricular, implantable
bridge-to-transplant system for full cardiac replacement, taking the
place of the failing heart in patients at imminent risk of death. The
device offers full circulatory support, the shortest blood path and
exposure to artificial surfaces, and the highest level of cardiac output
when compared with other artificial heart systems previously tested.
With the CardioWest TAH-t, patients become better candidates for
eventual transplantation and have post-transplant survival rates equal
to that of non-device cardiac recipients.
About SynCardia Systems
Founded in 2001, SynCardia Systems is the developer of biomechanical
cardiac replacement and assist devices. Its CardioWest Temporary Total
Artificial Heart (TAH-t) is designed for severely ill patients with
end-stage congestive heart failure. The device serves as an in-hospital
bridge-to-transplantation for patients at imminent risk of death.
SynCardia Systems is based in Tucson, Arizona and is on the Web at
http://www.syncardia.com.
Copyright: SeniorJournal.com |
