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WorldHeart Receives IRB Approval at First Center in the Levacor™ VAD BTT Clinical Trial Center On-Site Training Completed
SALT LAKE CITY, Oct. 15 /PRNewswire-FirstCall/ -- ("WorldHeart";
Nasdaq: WHRT) - World Heart Corporation (WorldHeart) announced
today that the Levacor Ventricular Assist Device (VAD)
Bridge-to-Transplant (BTT) Study has been approved by the
Institutional Review Board (IRB) at INTEGRIS Baptist Medical
Center in Oklahoma City. On-site clinical and technical training
has been conducted, formally qualifying this center as the first
for the Levacor Study.
Dr. Douglas Horstmanshof is the Program Director of the INTEGRIS
Baptist Heart Failure Institute and the center's Principal
Investigator for the Levacor trial. Dr. James W. Long is the
Study's Co-Investigator and the Director of INTEGRIS Advanced
Cardiac Care, which is the only ventricular assist device
program in Oklahoma. Both clinicians have long been active in
transplant and circulatory support therapies, and Dr.
Horstmanshof notes that "we are excited to participate in the
Levacor Study and to bring the potential benefits of this unique
fourth-generation VAD technology to our heart failure patients."
As previously announced, WorldHeart has conditional approval
from the FDA for the Levacor BTT Study for ten initial study
sites. Mr. J. Alex Martin, WorldHeart President and CEO said
that "we are eager to move forward into the clinical setting and
are extremely pleased to announce INTEGRIS Baptist's
qualification status. We also continue to work closely with
other participating hospitals as their IRBs review the Study
protocol."
The Levacor VAD is the only bearingless, fully magnetically
levitated, implantable centrifugal pump to enter clinical trial.
Mr. Jal S. Jassawalla, WorldHeart's Executive Vice President and
Chief Technology Officer, commented "our objective is to
demonstrate that this newer-generation technology will minimize
complications and provide long-lasting, dependable, performance.
We look forward to working with leading clinicians to
demonstrate Levacor's safety and efficacy."
About World Heart Corporation
WorldHeart is a developer of mechanical circulatory support
systems in Salt Lake City, Utah with additional facilities in
Oakland, California, USA and Herkenbosch, The Netherlands.
WorldHeart's registered office is in Ottawa, Ontario, Canada.
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 all statements
relating to the advancement of WorldHeart's clinical development
programs, the potential clinical benefits of the Levacor VAD,
and the growth of WorldHeart's overall business, 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: WorldHeart's need
for additional capital in the future; risks in product
development, regulatory approvals and market acceptance of and
demand for WorldHeart's products; successful completion of the
Levacor VAD Bridge-to-Transplant Study; and other risks detailed
in WorldHeart's filings with the U.S. Securities and Exchange
Commission, including without limitation its Annual Report on
Form 10-K for the year ended December 31, 2008 and its Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2009 and
June 30, 2009.
www.worldheart.com
Source
World Heart Corporation
Mr. Morgan Brown of World Heart Corporation, +1-801-303-4361
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