World Heart Submits IDE Application for Levacor VAD

World Heart Corporation has submitted an FDA Investigational Device Exemption application for a pivotal bridge-to-transplant study of its Levacor Ventricular Assist Device (VAD).

Ventricular assist devices are mechanical pumps that enable the restoration of normal blood circulation in patients suffering from late-stage congestive heart failure. Levacor is intended for use as a bridge-to-transplant device for cardiac transplant candidates with left ventricular failure. The study’s primary endpoint will be survival to heart transplant.

Levacor is World Heart’s fourth-generation rotary VAD. The bearingless device incorporates “MagLev”, a fully magnetically levitated rotary pump. Full magnetic levitation eliminates wear within the pump, it also permits greater clearances and optimized blood flow around the impeller (an impeller is a propeller-like device that mimics the pumping action of the heart).

“We look forward to the FDA’s initial review of this submission and will answer, in supplemental submissions, any Agency questions or requests,” said Jal Jassawalla, World Heart’s President and CEO.

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