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1994.10.03 :  Heart-Assist Device

Contact:  Sharon Snider (FDA) (301) 443-3285
Oct. 3, 1994


                  FDA APPROVES HEART ASSIST DEVICE

     FDA today approved the first heart-assist device to help keep
patients alive while they await heart transplants.  By pumping blood
through the body, the device helps do the heart's work until a donor
heart is available.

     The device--the HeartMate Implantable Pneumatic Left
Ventricular Assist System--consists of an implanted blood pump
connected by a cable to an external computerized console which
powers the pump.  The pump is designed to assist the left side of
the heart.  

     "This device could help save the lives of many transplant
candidates who now die for lack of available donor hearts," said FDA
Commissioner David A. Kessler, M.D. 

     Currently, heart transplant candidates are treated with drugs
or intra-aortic balloon pumps.  But these treatments only provide
partial help for a short time, and to stay alive, patients need a
heart transplant.  Because the supply of donor hearts is limited,
some heart patients must wait over a year before one becomes
available.  Almost half die waiting.

     FDA's decision to approve the device  is based on a review 
of safety and effectiveness data submitted by the manufacturer, 
Thermo Cardiosystems Inc. of Woburn, Mass.  The data were derived 
from a long-term clinical study begun in 1985.  The study, 
which included 162 patients, was conducted at 17 institutions in the
United States.

     The blood pump is implanted in the abdominal cavity and
connected to the left ventricle, the main pumping chamber of the
heart.  From there, blood is pumped by the device into the main
artery supplying the body with blood.

     The external console is mounted on a mobile cart and plugged
into an electrical outlet.  It can also operate on batteries for up
to 30 minutes, allowing the patient freedom to move the console
during walks or exercise in the hospital.  The device remains
implanted until the patient receives a donor heart.


     The heart-assist system is approved for use in patients over 18
with non-reversible heart failure when their condition is
deteriorating so rapidly they are likely to die within 24 to 48
hours.  The patients must be on their hospital's transplant list in
order to qualify for the device.

     In approving the product, FDA followed the recommendation of
its  Circulatory System Devices Advisory Panel, which met in
December to review the device.

     An estimated 15,000 to 20,000 people are potential candidates
for heart transplants yearly in the United States.  But there are
only enough donor hearts for about 2,000 people.  Some of the others
who meet the eligibility criteria could be candidates for
the heart-assist device.

     FDA is one of eight Public Health Service agencies within HHS.

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