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8-K - WORLD HEART CORP | v210521_8k.htm |
Exhibit
99.1
WorldHeart
Pauses Enrollment in the Levacor® VAD Bridge-to-Transplant Study
Salt Lake City, UT – February 9,
2011: 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.
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.
This news
release was distributed by GlobeNewswire, www.globenewswire.com
www.worldheart.com
SOURCE
World Heart Corporation
Mr.
Morgan Brown of World Heart Corporation, +1-801-303-4361