OAKLAND, Calif., Sept. 6 /PRNewswire-FirstCall/ -- (Nasdaq: WHRT, TSX: WHT) World Heart Corporation (WorldHeart), a developer of mechanical circulatory support systems, announced successful completion of the first multi-day animal study of a miniaturized, pediatric, ventricular assist device (VAD). The PediaFlow(TM), developed by a National Institutes of Health-funded consortium including WorldHeart, is expected to be the platform for a future minimally invasive adult VAD, intended to meet a large clinical need for earlier-stage heart failure patients.
The animal implant was performed by Peter Wearden, M.D., Ph.D., pediatric cardiac surgeon at the Children's Hospital of Pittsburgh. The six-day study, at the University of Pittsburgh McGowan Institute, focused on hemodynamic performance and biocompatibility under physiologic conditions. The device provided uninterrupted support and met all design targets. Biocompatibility was demonstrated, with no indications of blood damage or clotting.
Dr. Harvey Borovetz, the Robert L. Hardesty Professor of Surgery, Chairman of Bioengineering at the University of Pittsburgh and Principal Investigator of the associated NIH PediaFlow development contract, remarked that, "With the success of the recent in vivo experiments, we are encouraged to begin 30-day animal implants, focusing again on pump performance and biocompatibility."
Mr. Jal Jassawalla, WorldHeart's President and CEO, commented, "The positive results of the initial in vivo implants highlight the potential benefits of WorldHeart's MagLev(TM) technology. We are excited that this technology, first embodied in the Levacor(TM) VAD, is being extended to the pediatric VAD and then potentially to a WorldHeart minimally invasive adult VAD." The latter, providing partial circulatory support, would serve a broad population with less advanced heart failure. Such a device would complement WorldHeart's Levacor VAD, which is intended to provide a greater degree of support to patients in advanced heart failure. A U.S. feasibility-phase bridge-to-transplant study of the Levacor VAD is planned to begin in late 2007 or early 2008. WorldHeart has been interacting with the FDA regarding final pre-clinical qualification testing and the clinical protocol for the upcoming study.
About the Levacor VAD
The Levacor is a next-generation rotary VAD. It is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump with clinical experience. An advanced, continuous-flow pump, the Levacor VAD uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. The proprietary levitation technology employs a unique arrangement of magnetics expected to provide optimal system simplicity and reliability. In contrast to pumps with blood-immersed mechanical or hydrodynamic bearings, full magnetic levitation eliminates wear within the pump as well as eliminates dependence on blood properties for rotor suspension. It is expected to provide improved blood compatibility by allowing greater clearances around the rotor and more idealized flow patterns across a wider range of operation. The Levacor VAD has been designed with a high safety profile and robust range of operation to address the needs of current and future heart failure patients.
About the PediaFlow VAD
The PediaFlow VAD is an implantable, magnetically levitated rotary blood pump based on WorldHeart's proprietary MagLev technology. Configured for pediatric use, the PediaFlow VAD is being developed to provide medium-term (< 1 year) implantable circulatory support to patients from birth to 2 years of age with congenital or acquired heart disease. PediaFlow design and development is funded by the National Institutes of Health and involves a consortium that encompasses the University of Pittsburgh, Children's Hospital of Pittsburgh, the University of Pittsburgh Medical Center, the Artificial Heart Program at LDS Hospital in Salt Lake City, Primary Children's Medical Center in Salt Lake City, LaunchPoint Technologies, Carnegie-Mellon University and WorldHeart.
WorldHeart is a developer of mechanical circulatory support systems with leading next-generation technologies. The Company is headquartered in Oakland, California, 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 statements regarding the Company's expectations with respect to the Company's future development plans for its next-generation Levacor VAD and PediaFlow VAD, including the timing and scope of clinical trials, the potential scope of use and clinical benefits of these devices, 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, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements, including without limitation: delays in development, preclinical qualification and regulatory approvals, and clinical trials; Destination Therapy adoption rate for VADs; competition, the need for additional financing; and other risks detailed in the Company's filings with the United States Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2006, as amended.
|SOURCE World Heart Corporation|
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