OAKLAND, Calif., Jan. 8 /CNW/ -- (Nasdaq: WHRT) World Heart Corporation
("WorldHeart") announced today that it has submitted an Investigational Device
Exemption ("IDE") application to the US Food and Drug Administration ("FDA" or
the "Agency") for a pivotal Bridge-to-Transplant ("BTT") study of the
Levacor(TM) Ventricular Assist Device ("VAD").
The IDE application includes detailed device information, including
design and in vitro and in vivo preclinical testing protocols and results.
The submission also encompasses an Investigational Plan and extensive
study-related materials. The Levacor VAD is intended for use, inside and
outside of the hospital, as a BTT in cardiac transplant candidates with
presumed non-reversible left ventricular failure. The proposed primary study
endpoint comprises survival to heart transplantation, explant for myocardial
recovery, or survival to 180 days on device support.
"This IDE submission marks an important milestone for WorldHeart,"
commented Mr. Jal S. Jassawalla, President and CEO of WorldHeart. "We look
forward to the FDA's initial review of this submission and will answer, in
supplemental submissions, any Agency questions or requests. We are eager to
progress to the clinical study stage in collaboration with many key clinicians
in this field who have expressed a strong interest in participating."
WorldHeart's Levacor VAD, a fourth-generation rotary VAD, is the only
bearingless, fully magnetically levitated implantable centrifugal rotary pump
to have seen clinical use. In contrast with second- and third-generation
pumps with blood-immersed mechanical or hydrodynamic bearings, the Levacor
uses full magnetic levitation to suspend the spinning rotor, eliminating wear
within the pump and allowing greater clearances around the rotor for blood
About World Heart Corporation
WorldHeart is a developer of mechanical circulatory support systems.
WorldHeart is headquartered in Oakland, California, USA with additional
facilities in Salt Lake City, Utah and Herkenbosch, The Netherlands.
WorldHeart's registered office is 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 regarding WorldHeart's ability to obtain FDA
approval for the Levacor(TM) VAD and the conduct of the proposed clinical
study, as well as other statements that can be identified by the use of
forward-looking language, such as "will" or "intends", or by discussions of
strategy or intentions. Investors are cautioned that all forward looking
statements involve risk and uncertainties, including without limitation:
WorldHeart's ability to obtain FDA approval for the Levacor(TM) VAD, risks in
product development 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-KSB/A for the year ended December 31, 2007 and its Quarterly
Report on Form 10-Q/A for the quarter ended March 31, 2008 and its Quarterly
Reports on Form 10-Q for the quarters ended June 30, 2008 and September 30,
For further information:
For further information: Mr. David Pellone, +1-510-563-4775, or Ms.
Peggy Allman, +1-510-563-4721, both of World Heart Corporation Web Site: