WorldHeart Announces Further Milestone in Miniaturized Assist Pump Development
The animal implant was performed by Peter Wearden, M.D., Ph.D., pediatriccardiac surgeon at the Children's Hospital of Pittsburgh. The six-day study,at the University of Pittsburgh McGowan Institute, focused on hemodynamicperformance and biocompatibility under physiologic conditions. The deviceprovided uninterrupted support and met all design targets. Biocompatibilitywas demonstrated, with no indications of blood damage or clotting.
Dr. Harvey Borovetz, the Robert L. Hardesty Professor of Surgery, Chairmanof Bioengineering at the University of Pittsburgh and Principal Investigatorof the associated NIH PediaFlow development contract, remarked that, "With thesuccess of the recent in vivo experiments, we are encouraged to begin 30-dayanimal implants, focusing again on pump performance and biocompatibility."
Mr. Jal Jassawalla, WorldHeart's President and CEO, commented, "Thepositive results of the initial in vivo implants highlight the potentialbenefits of WorldHeart's MagLev(TM) technology. We are excited that thistechnology, first embodied in the Levacor(TM) VAD, is being extended to thepediatric VAD and then potentially to a WorldHeart minimally invasive adultVAD." The latter, providing partial circulatory support, would serve a broadpopulation with less advanced heart failure. Such a device would complementWorldHeart's Levacor VAD, which is intended to provide a greater degree ofsupport to patients in advanced heart failure. A U.S. feasibility-phasebridge-to-transplant study of the Levacor VAD is planned to begin in late 2007or early 2008. WorldHeart has been interacting with the FDA regarding finalpre-clinical qualification testing and the clinical protocol for the upcomingstudy.
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 clinicalexperience. An advanced, continuous-flow pump, the Levacor VAD uses magneticlevitation to fully suspend the spinning rotor, its only moving part, inside acompact housing. The proprietary levitation technology employs a uniquearrangement of magnetics expected to provide optimal system simplicity andreliability. In contrast to pumps with blood-immersed mechanical orhydrodynamic bearings, full magnetic levitation eliminates wear within thepump as well as eliminates dependence on blood properties for rotorsuspension. It is expected to provide improved blood compatibility byallowing greater clearances around the rotor and more idealized flow patternsacross a wider range of operation. The Levacor VAD has been designed with ahigh safety profile and robust range of operation to address the needs ofcurrent and future heart failure patients.
About the PediaFlow VAD
The PediaFlow VAD is an implantable, magnetically levitated rotary bloodpump based on WorldHeart's proprietary MagLev technology. Configured forpediatric use, the PediaFlow VAD is being developed to provide medium-term(< 1 year) implantable circulatory support to patients from birth to 2 yearsof age with congenital or acquired heart disease. PediaFlow design anddevelopment is funded by the National Institutes of Health and involves aconsortium that encompasses the University of Pittsburgh, Children's Hospitalof Pittsburgh, the University of Pittsburgh Medical Center, the Artificial
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