|
WorldHeart Announces First U.S. Implant
of Levacor™ VAD Implant at INTEGRIS in Oklahoma City
SALT LAKE CITY, Jan 19, 2010 /PRNewswire via COMTEX/ -- World
Heart Corporation ("WorldHeart") (Nasdaq: WHRT), a developer of
mechanical circulatory systems, announced today that the first
U.S. implant of the Levacor Ventricular Assist Device ("VAD")
was successfully performed at INTEGRIS Baptist Medical Center
("INTEGRIS") in Oklahoma City on Wednesday, January 13, 2010.
This is the first implant in the Levacor VAD
bridge-to-transplant ("BTT") study, which is expected to enroll
160 patients, pursuant to a recently approved U.S.
Investigational Device Exemption Application. INTEGRIS is the
first of the initial ten BTT clinical study sites.
The recipient, an Oklahoma native, is a 59- year-old woman
suffering from severe cardiomyopathy, or a weakened heart
muscle. Dr. Craig Elkins, cardiac surgeon and INTEGRIS' surgical
Principal Investigator for the study commented, "The device
implant was remarkably smooth with a relatively short procedure
and the patient is recovering quickly from her surgery. We are
excited to participate in the study and pleased to offer to our
patients this new technology."
Mr. J. Alex Martin, WorldHeart's President and Chief Executive
Officer added, "We are especially pleased to reach this
important milestone and are gratified to provide this therapy to
bridge those waiting for a donor heart."
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
trial. 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 with additional facilities
in Oakland, California, USA and Herkenbosch, The Netherlands.
WorldHeart's registered office is in Delaware, USA.
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 first implant in the
bridge-to-transplant clinical study of the Levacor Ventricular
Assist Device, strategic direction, increase in shareholder
value, access to investment capital, its clinical development
programs and the product pipeline, 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:
risks involved in the clinical trials of the Levacor Ventricular
Assist Device, 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, June 30, 2009 and September 30, 2009.
Source
World Heart
Corporation
|
