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US trial go-ahead sought for replacement heart:

This article was originally published in Clinica

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Executive Summary

Abiomed has submitted an investigational device exemption to the US FDA for permission to begin human trials of its AbioCor implantable replacement heart. The Danvers, Massachusetts-based company plans to assess the device's ability to improve life expectancy and provide a reasonable quality of life in selected patients who are in end-stage heart failure and who are not candidates for heart transplantation or any other therapy.

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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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