University of Louisville/Jewish
Hospital Team Meets Initial Goal in Replacement Heart Research
Research team demonstrates procedure consistency
with AbioCor Replacement Heart
(LOUISVILLE) -- Members of the team
conducting final phases of pre-clinical readiness demonstration
for ABIOMED Inc.s replacement heart announced today that
the first goal has been met. The surgical research team from Jewish
Hospital and the University of Louisville have demonstrated procedure
consistency and team readiness in laboratory implantation of the
AbioCor replacement heart. The UofL/Jewish Hospital team
has shown that this new procedure can be successfully performed
in a laboratory setting with regularity, demonstrating that the
device is reliable and that the team is ready to continue with
the project in more advanced trials.
The AbioCor replacement heart
is totally implanted and is designed to replace the full pumping
function of the human heart. It is uniquely designed for use by
patients with irreparable damaged hearts and at risk of death
due to acute myocardial infarction (heart attack), chronic ischemic
disease or other forms of end-stage heart failure.
The complete AbioCor system consists
of the actual pump ("the heart"), which is implanted
in the chest in place of the diseased natural heart, and associated
components which are implanted in the abdomen. These components
include the battery, and electronic control unit ("the brain")
and a transcutaneous energy transmission system that transmits
power from the outside to the inside of the body without piercing
the skin. Patients will carry rechargeable external batteries
to power the system and recharge the internal batteries.
"Our team of surgeons, perfusionists,
nurses and technicians have met all defined criteria for successful
implantation," explained project co-principal investigator
Laman A. Gray, Jr, MD, a Jewish Hospital and University of Louisville
surgeon. "We have demonstrated that this device can be used
consistently and successfully."
The partnership of ABIOMED, Jewish
Hospital and the University of Louisville was announced just over
one year ago. At that time, team readiness was identified as a
primary goal. "We have put together an outstanding group
of researchers and clinicians," commented Robert D. Dowling,
MD, project co-principal investigator and University of Louisville/Jewish
Hospital surgeon. "This project has run exceptionally well,
especially considering the large scope of work."
The partnership has attained other
achievements over the past year, to include refinements to the
device itself. "ABIOMED has been extremely responsive to
our questions and suggestions," Dr. Gray continued. "They
have truly treated the collaboration as a partnership."
Dr. David Lederman, ABIOMEDs
CEO, expressed appreciation and respect with the remarkable progress
achieved by the Lousiville team. "We have had a long history
of successful collaboration with Dr. Grays team in the development
and clinical introduction of life-saving technologies," Dr.
Lederman explains. "As we achieve technical and program milestones
with the AbioCor, we grow more optimistic about our ability to
SUCCEED WITH this, the most ambitious device technology undertaking
in cardiac medicine."
According to Dr. Lederman, "the
AbioCor program now comprises more than 70 full-time engineers,
scientists and technical support personnel at ABIOMED alone, plus
a large number of highly skilled specialists working with us in
at the selected centers."
The team is currently focusing on the
refinement of pharmacological management regimens and other pre-
and post-surgical advances. These include development of clinical
study design, implantation protocols, software tools, post-implantation
logistics AND FINALIZING CONVERSION OF THE REPLACEMENT HEART DESIGN
FROM BOVINE TO HUMAN CONFIGURATION.
Dr. Laman Gray is an internationally
recognized leader in the fields of minimally invasive surgery
and development of artificial hearts. Dr. Grays outstanding
accomplishments include performing the first heart transplant
in Kentucky (1984) and the first clinical use of ABIOMEDs
SupraCor® IABP (1992). He was also one of the four primary
clinical investigators that brought ABIOMEDs BVS-5000®
temporary cardiac support system to clinical approval by the FDA
(1992). He has been the Director of the University of Louisville
School of Medicines Division of Thoracic and Cardiovascular
Surgery for more than 20 years and is a founding member of the
Jewish Hospital Heart and Lung Institute.
Dr. Robert Dowling, Associate Professor
of Surgery at the University of Louisville, received his training
in Cardiothoracic Surgery at the University of Pittsburgh. Dr.
Dowling performed the first double-lung transplant (1995) and
the first ventricular remodeling (1996) in Kentucky. Dr. Dowling
is Director of the Jewish Hospital / University of Louisville
Heart Transplant and Cardiac Assist Devices Program and Director
of the Kosair Childrens Hospital Heart Transplant Program.
Based in Danvers, Massachusetts, ABIOMED,
Inc. develops, manufactures and markets innovative cardiovascular,
medical and dental products and is a technology leader in the
research and development of advanced artificial heart systems.
Jewish Hospital among 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.
This research has been made possible,
in part, by the Jewish Hospital Foundation.