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US trial go-ahead sought for replacement heart:

This article was originally published in Clinica

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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