LOUISVILLE PHYSICIANS DISCUSS FDA APPROVAL FOR
ABIOMED TO BEGIN HUMAN IMPLANTS OF ARTIFICIAL HEART
(LOUISVILLE, Ky.) -- Physicians from
the University of Louisville and Jewish Hospital gathered today
to discuss the recent announcement by ABIOMED, Inc., that it had
received permission from the Food and Drug Administration (FDA)
to begin the initial clinical trial of its AbioCor Replacement
Jewish Hospital, in partnership with
the University of Louisville, is among a select group of five
U.S. medical centers that have been working with ABIOMED to further
develop the totally implantable replacement device.
"We have been working with ABIOMED
for the last three years on this project. We believe this device
is very reliable and are pleased that the FDA has approved the
next phase of this project," said Laman A. Gray, Jr., M.D.,
Co-Principal Investigator. "While we have received the go-ahead,
we do not know when the first procedure will occur because there
are still several minor steps that must be taken internally before
the first procedure takes place. This is the most sophisticated
medical device that has ever been developed for implantation.
We have been extremely methodical and cautious in our research
to date and will continue to exercise the same restraint as we
approach an actual implantation."
The AbioCor, the worldâs first
implantable artificial heart, is intended as a permanent replacement,
not a bridge, for end-stage heart failure patients who are at
risk of imminent death, are not transplantable, and cannot be
helped by other available therapies. These patients are not candidates
for transplant and cannot be helped by any other available therapy.
"This technology could be the
next critical step in saving patients with end-stage heart disease
and no other chance for survival," Robert Dowling, M.D.,
Co-Principal Investigator explains. "The AbioCor heart replacement
device could be a permanent solution for these patients, giving
them another opportunity for an extended life."
The Investigational Device Exemption
(IDE) granted by the FDA allows for the implantation of the AbioCor
in the first five patients of the clinical trial. Success of the
trial will be based upon periodic review of the survival of AbioCor
patients and their quality of life as measured by a variety of
assessment instruments previously validated for end stage heart
"Jewish Hospital is proud to continue
being part of ground breaking research which will impact patients
in this region and around the world," said John Oldfather,
Ph.D., Vice President and Administrator of the Jewish Hospital
Heart and Lung Institute. "Our commitment to this type of
research is unparalleled, as evidenced by our long relationship
with the University of Louisville."
Jewish Hospital is one of the top ten
cardiac centers in the United States, and along with the University
of Louisville, is dedicated to excellence in clinical care, research
and education. Jewish Hospital is one of only a few facilities
in the world offering a complete range of surgical treatments
for end-stage heart failure, including transplantation, ventricular
assist devices, cardiomyoplasty and ventricular remodeling.