WorldHeart Receives US Clinical Study Approval for the Levacor(TM) VAD


    SALT LAKE CITY, Aug. 20 /CNW/ -- ("WorldHeart") (Nasdaq:   WHRT) - World
Heart Corporation (WorldHeart) announced today that it has received FDA
conditional approval to begin a bridge-to-transplant (BTT) study of the
Levacor Ventricular Assist Device (VAD) at ten US centers.

    The company is required to provide some additional information to the FDA
within 45 days, but the study is permitted to begin upon receipt of clinical
center Institutional Review Board (IRB) approvals.  WorldHeart has been
working closely with a number of clinicians and clinical sites that are
interested in participating in the Levacor Study.

    Center expansion beyond the initial ten sites will be based upon a
supplemental IDE application and subsequent FDA approval.  Study enrollment
will involve approximately 200 subjects, with an opportunity to demonstrate
statistical significance through a planned interim analysis at approximately
150 subjects.

    "We are extremely pleased to reach this key milestone in the development
and clinical implementation of the Levacor VAD," said Mr. J. Alex Martin, 
WorldHeart's President and CEO.  "We are also pleased that the clinical study
has been assigned CMS category B2, which makes insurance reimbursement
possible. Finally, we believe that our unique assist technology will provide
life-saving potential for many heart-failure patients and further advance
mechanical circulatory support therapy."

    The Levacor VAD is the only bearingless, fully magnetically levitated,
implantable centrifugal pump to enter clinical trials.  The pump uses magnetic
levitation to fully suspend the spinning rotor, its only moving part, inside a
compact housing.  As described by Mr. Jal S. Jassawalla, WorldHeart's
Executive Vice President and Chief Technology Officer, "full magnetic
levitation eliminates dependence on blood properties for rotor suspension, as
well as wear within the pump.  This design is expected to optimize blood
compatibility by providing unobstructed clearances around the rotor, across a
wide range of operation.  We look forward to partnering with prominent
clinicians at leading transplant centers to demonstrate Levacor safety and

    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 and the growth of its 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; 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.


    Contact Information:
    World Heart Corporation
    Mr. J. Alex Martin  (801) 303-4352
    Ms. Peggy Allman  (510) 563-4721


For further information:

For further information: Mr. J. Alex Martin, +1-801-303-4352, or Ms.
Peggy Allman, +1-510-563-4721, both of World Heart Corporation Web Site:

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890