|
WorldHeart Receives US Clinical Study Approval for the Levacor™
VAD
SALT LAKE CITY, Aug. 20 /PRNewswire-FirstCall/ -- ("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 efficacy."
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
www.worldheart.com
Source
World Heart Corporation
|
