Six Leading Heart Failure Cardiologists and Cardiac Surgeons to Guide
Upcoming Rotary VAD US Clinical Trial
OAKLAND, Calif., March 26 /CNW/ -- (Nasdaq: WHRT; TSX: WHT) - World Heart
Corporation, a technology leader in mechanical circulatory support systems,
announced today that it has assembled a Clinical Trial Coordinating Committee
to direct the US clinical trial of the Levacor(TM) rotary ventricular assist
device (VAD), expected to begin later this year. The members of this committee
will provide leadership and clinical direction for the trial by developing the
study protocol, and working with clinical colleagues to share best practices,
address clinical issues and assist with the timely completion of the trial.
Committee members include:
Dr. James W. Long, cardiovascular surgeon, Director of the Utah
Artificial Heart Program at LDS Hospital and Adjunct Associate
Professor, Department of Bioengineering, University of Utah, Salt
Lake City, Utah. He is currently President of the American Society
for Artificial Internal Organs.
Dr. Stephanie Moore, cardiologist, Assistant in Medicine at
Massachusetts General Hospital and Instructor, Harvard Medical
School, Boston, Massachusetts. Her scope of practice includes
immediate and extended mechanical assist device therapy, cardiac
resynchronization therapy and transplantation. She participates in
the ISHLT, HFSA and ASAIO, and has lectured nationally and
internationally on innovative advanced heart failure therapies.
Dr. John B. O'Connell, cardiologist, Director of the Center for
Heart Failure, Bluhm Cardiovascular Institute and Professor of
Medicine, Feinberg School of Medicine, Northwestern University,
Chicago, Illinois. He has held numerous scientific leadership
positions, including President of the International Society for
Heart and Lung Transplantation and the Association of Professors of
Dr. Francis D. Pagani, cardiovascular surgeon, Associate Professor
of Surgery and Director, Adult Heart Transplantation and Artificial
Devices Program, Section of Cardiac Surgery, University of Michigan
Medical Center, Ann Arbor, Michigan.
Dr. Mark S. Slaughter, cardiovascular surgeon, Director of the
Mechanical Assist Device Program and Surgery for Congestive Heart
Failure at Advocate Christ Medical Center, Oak Lawn, Illinois.
Dr. Randall C. Starling, cardiologist, Professor of Medicine,
Section Head of Heart Failure and Cardiac Transplant Medicine at the
Cleveland Clinic and Medical Director of the hospital's Kaufman
Center for Heart Failure, Cleveland, Ohio. He is a member of the
Board of Directors of the International Society of Heart and Lung
Transplantation, and serves on the Guidelines Committee of the Heart
Failure Society of America.
Mr. Jal Jassawalla, WorldHeart President and CEO, commented, "We are
pleased to have the support of these distinguished clinicians, and excited
about the anticipated clinical use of the Levacor in the US. WorldHeart is
now the only experienced VAD manufacturer actively developing a next-
generation, bearingless, fully magnetically levitated centrifugal device.
Based on the unique design of this VAD and our initial clinical success in
Greece, we anticipate that the upcoming US trial will validate the advantages,
to the patients, of this advanced technology."
Levacor Clinical Trials
The US clinical trial will begin with a feasibility study as a bridge to
cardiac transplantation (BTT), planned to start in the fourth quarter of this
year. A subsequent pivotal study is expected to result in market clearance of
the device for both BTT and Destination Therapy. The US study follows an
initial feasibility trial in Greece, in which the device was successfully used
to treat two patients as a bridge to recovery of the diseased native heart.
Two hospitals in Canada -- Toronto General Hospital and the University of
Ottawa Heart Institute -- are currently approved to implant the Levacor rotary
VAD as a bridge to cardiac transplant under Health Canada's Therapeutic
Product Directorate Special Access Program.
Dr. Pagani said, "We eagerly anticipate gaining access to this unique,
next-generation device. We believe its use of a bearingless, magnetically
levitated rotor provides the potential for superior blood handling
characteristics, range of operation and margin of safety."
Dr. O'Connell stated, "We are looking forward to participating in the US
trial of the Levacor VAD. We are also excited to be participating in the
design of an innovative pivotal clinical study protocol, which is expected to
reduce the duration of the trial, number of patients to be studied and the
time needed to attain marketing approval."
"We are pleased to have assembled such an outstanding team of clinicians
to help direct this important study," said Dr. Piet Jansen, Chief Medical
Officer of WorldHeart. "With their support and guidance, we anticipate that
this study will represent a significant advancement in the field of mechanical
circulatory support, while making this potentially life-saving therapy
available to a wider population of heart failure patients."
About the Levacor VAD
The Levacor VAD is a next-generation rotary VAD. It is the only
bearingless, fully magnetically levitated implantable centrifugal rotary pump
in clinical trials. An advanced, continuous-flow pump, the Levacor uses
magnetic levitation to fully suspend the spinning rotor, its only moving part,
inside a compact housing. The proprietary levitation technology employs a
unique arrangement of magnetics expected to provide optimal system simplicity
and reliability. In contrast to pumps with blood-immersed mechanical or
hydrodynamic bearings, full magnetic levitation eliminates wear within the
pump as well as dependence on blood properties for rotor suspension, and is
expected to provide improved blood compatibility by allowing greater
clearances around the rotor and more idealized flow patterns across a wider
range of operation. The Levacor VAD has been designed with the objective of
addressing the needs of current and future heart-failure patient populations
with a high safety profile and robust range of operation.
About World Heart Corporation
WorldHeart is a developer of mechanical circulatory support systems with
leading next-generation technologies. The Company is headquartered in
Oakland, California, USA with additional facilities in Salt Lake City, Utah
and Heesch, The Netherlands. WorldHeart's registered office is Ottawa,
Any forward-looking statements in this release are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995
and include statements regarding the Company's expectations with respect to
the Company's future development plans for its next-generation Levacor VAD,
including the timing and scope of clinical trials, as well as, other
statements that can be identified by the use of forward-looking language, such
as "believes," "feels," "expects," "may," "will," "should," "seeks," "plans,"
"anticipates," or "intends" or the negative of those terms, or by discussions
of strategy or intentions. Investors are cautioned that all forward-looking
statements involve risk and uncertainties, including without limitation:
delays in development, preclinical qualification and regulatory approvals of
the Levacor VAD; costs and delays associated with clinical trials; limitations
on third-party reimbursement; inability to protect proprietary technology;
continued slower Destination Therapy adoption rate for VADs; need for
additional financing; and other risks detailed in the Company's filings with
the United States Securities and Exchange Commission, including its Current
Report on Form 8-K filed on December 22, 2006 and its upcoming Annual Report
on Form 10-KSB for the year ended December 31, 2006.
For further information:
For further information: Mr. Richard Juelis, +1-510-563-4713, or Ms.
Peggy Allman, +1-510-563-4721, both of World Heart Corporation Web Site: