WorldHeart Announces Levacor(R) VAD Implant at Tampa General Hospital; Enrollment in Bridge-to-Transplant Study Continues to be
2011年1月12日 - 11:00PM
World Heart Corporation (WorldHeart) (Nasdaq:WHRT), a developer of
mechanical circulatory systems, announced today that Tampa General
Hospital (Tampa General) in Tampa, Florida has successfully
implanted its first Levacor Ventricular Assist Device (VAD). Tampa
General is the sixth implanting site nationwide in the Levacor VAD
Bridge-to-Transplant (BTT) Study. This is the 15th implant with the
Levacor VAD since the inception of the BTT Study.
WorldHeart also announced that three refinements are being made
to its Levacor VAD based on initial experience. As a result,
enrollment will continue to be slow in the BTT Study until the
refinements are completed. 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. WorldHeart
expects that implementation will take approximately two months, and
anticipates that Study enrollment will accelerate once the
refinements are complete.
"We are very excited to add Tampa General to the list of
implanting centers and are encouraged by many of the BTT Study
findings to date," noted Mr. J. Alex Martin, President and CEO.
"However, we feel that it's worthwhile to implement these
refinements. The Levacor VAD is a highly innovative device and we
intend to maximize all of its potential attributes for the benefit
of the patients who receive it."
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 BTT clinical study of the Levacor
VAD, including those related to the implants of the Levacor VADs,
level of WorldHeart's clinical experience, the progress of
WorldHeart's clinical development program, and the timing for
WorldHeart to make the device refinements and the enrollment rate
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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