Healthcare Industry News: Rotary VAD
News Release - July 16, 2007
WorldHeart Announces Milestone in Miniaturized Assist Pump Development
OAKLAND, Calif., July 16 (HSMN NewsFeed) -- (Nasdaq: WHRT ; TSX: WHT ) -- World Heart Corporation (WorldHeart), a developer of mechanical circulatory support systems, announced a successful animal implant of a miniaturized, pediatric, ventricular assist device (VAD). The PediaFlow(TM) design also is the platform for a future minimally invasive adult VAD, intended to meet a large clinical need for earlier-stage heart failure patients.The acute implant, at the University of Pittsburgh Medical Center, focused on initial biocompatibility and mechanical function under physiologic conditions. Encouraging bench testing results led to the animal implant, performed by Peter Wearden, MD, PhD and assisted by Robert Kormos, MD (cardiac surgeons at the Children's Hospital of Pittsburgh and the University of Pittsburgh Medical Center, respectively).
The PediaFlow VAD is an implantable, magnetically levitated blood pump based on WorldHeart's proprietary Rotary VAD MagLev(TM) technology. In its pediatric configuration, the device is designed to provide a flow rate from 0.3 to 1.5 L/min. Development is funded by the National Institutes of Health, and involves a consortium that includes the University of Pittsburgh, Children's Hospital of Pittsburgh and WorldHeart.
Dr. Harvey Borovetz, the Robert L. Hardesty Professor of Surgery, Chairman of Bioengineering at the University of Pittsburgh and Principal Investigator of the NIH contract remarked that, "The results of this first animal implant met our expectations and are very encouraging. It is gratifying to demonstrate in vivo that WorldHeart's Levacor(TM) MagLev technology can be applied to a miniaturized VAD. We look forward to its further development, including chronic implants, and to our goal of providing clinical benefit for newborns and infants."
Mr. Jal Jassawalla, WorldHeart's President and CEO, commented that, "WorldHeart is extremely pleased to participate in the development of this technology for infants. We are also excited about potential adaptation to a broad, adult, population with less advanced heart failure. We believe that pump miniaturization will allow implantation of the adult configuration using minimally invasive surgical techniques. This represents a complementary addition to the existing Levacor device."
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 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 dependence on blood properties for rotor suspension, and 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 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.
About 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
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