WorldHeart Pauses Enrollment in the Levacor(R) VAD Bridge-To-Transplant Study
February 09 2011 - 8:55AM
World Heart Corporation (WorldHeart) (Nasdaq:WHRT), a developer of
mechanical circulatory systems, announced today that it has paused
enrollment in its Levacor Ventricular Assist Device (VAD)
Bridge-To-Transplant (BTT) Study pending U.S. Food and Drug
Administration (FDA) review and approval of the previously
announced device refinements.
These refinements are the projection of the inflow cannula into
the ventricle, the elimination of a false alarm that has led to
controller exchanges and the optimization of surface
finishing/coating manufacturing processes. Although WorldHeart
still expects that the design modifications will be technically
ready in the next two to three months, in light of ongoing
communications with the FDA, the timeline for implementation is
dependent on review and approval by the FDA which is
uncertain.
About the Levacor VAD and World Heart
Corporation
The Levacor VAD is the only fully magnetically levitated,
bearingless, implantable centrifugal pump to move into clinical
trials. By using magnetic levitation to fully suspend a
spinning rotor, the Levacor VAD's only moving part, the pump is
designed to eliminate wear and to provide unobstructed clearances
for blood flow across a wide range of operation.
WorldHeart is a developer of mechanical circulatory support
systems based in Salt Lake City, Utah.
The World Heart Corporation logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7572
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
WorldHeart's Levacor VAD and the timing for WorldHeart to make the
device refinements and the timing of resuming enrollment in the BTT
Study. Investors are cautioned that all forward-looking statements
involve risk and uncertainties, including without limitation: risks
involved in the clinical trial of the Levacor VAD; 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, 2009 and its Quarterly Reports
on Form 10-Q for March 31, 2010, June 30, 2010 and September
30, 2010.
www.worldheart.com
CONTACT: Mr. Morgan Brown of World Heart Corporation, +1-801-303-4361
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