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Artificial heart panel review

This article was originally published in The Gray Sheet

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Executive Summary

FDA's Circulatory System Devices Panel will feature cardiologists as well as cardiovascular surgeons when it convenes June 23 to review Abiomed's AbioCor, according to the firm. In an April 20 release, Abiomed notes it is pursuing a humanitarian device exemption for the product, supported by data from 15 patients, having filed with FDA in September 2004. Plans for a PMA will hinge on a timetable for AbioCor 2, currently in animal studies. The next-generation device could last longer, yet be 35% smaller than AbioCor, Abiomed notes...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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