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WorldHeart Submits IDE Application For Study Of Levacor VAD

World Heart Corporation has submitted an Investigational Device Exemption ("IDE") application to the US Food and Drug Administration for a pivotal Bridge-to-Transplant ("BTT") study of the Levacor 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 extensive study-related materials and an investigational plan. The device 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 endpoint of the study 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." Levacor VAD, a fourth-generation rotary VAD, is a 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 device uses full magnetic levitation to suspend the spinning rotor, eliminating wear within the pump and allowing greater clearances around the rotor for blood flow.