UCLA set to begin clinical trials of transplant program by 2000

Wednesday, May 27, 1998

UCLA set to begin clinical trials

of transplant program by 2000

HEALTH: School to collaborate with ABIOMED to advance technology
of artificial heart

By Kathryn Combs

Daily Bruin Staff

The UCLA Heart Transplant Program will perhaps be the first to
begin clinical trials with a newly developed artificial heart
because of a collaborative agreement made earlier this month with
ABIOMED Inc.

With more than 3,500 Americans awaiting heart transplants each
year, the new device has the potential to prevent future loss of
life.

"There are almost 10 times the number of patients who would
benefit from a heart as there are hearts available," said Dr.
Hillel Laks, director of the UCLA Heart and Lung Transplant
Programs. ABIOMED estimates this device could save over 60,000
people annually nationwide.

UCLA plans to begin human clinical trials by the year 2000 as a
result of this agreement.

Manufactured by ABIOMED Inc., the technology on which the new
device is based was originally developed in 1977. However, clinical
trials of the original device in the 1980s were largely
unsuccessful because of problems with the heart.

Since the original trials, technological advances have greatly
improved the efficacy of the device, Laks said, although this is
not the first time testing an artificial heart.

"Advances in science and technology in the past decade have been
enormous and have resolved many issues associated with past
artificial heart problems," he said.

The program hopes this new device will save the lives of
patients for whom transplantation or corrective surgery is not
possible.

The ABIOMED replacement heart is a mechanical substitute for the
human heart that consists of two pumping chambers and does not
require any tubes or wires through the skin, in contrast with older
models. The device is implanted in the chest cavity in place of the
diseased heart, which is removed.

According to Laks, the device’s ability to be implanted is what
makes it unique. "It can be implanted with no lines, and it also
has a power source which can be recharged."

In addition, demographic changes have created an increased need
for artificial hearts.

"The population is getting older," said Dr. Daniel Marelli.
"People are going over from the donor side to the receiving. We
need alternatives to heart transplantation."

Marelli further explained that because of various medical and
physical conditions, some may not be eligible for heart
transplants.

"We need to have … many different options for many different
situations and for many different individuals," he said.

While this new artificial heart is now in the advanced stages of
preclinical testing, UCLA and ABIOMED are hopeful regarding the
potential of the new device.

"We are delighted that this world-renowned medical center and
its distinguished medical team have joined our efforts to bring
cardiac surgery to its most exciting and ambitious frontier: the
permanent replacement of the human heart with a viable synthetic
device," said Dr. David Lederman, president of ABIOMED.

ABIOMED Inc. manufactures and markets cardiovascular, medical
and dental products and is said to be a leader in the development
of advanced heart systems.

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