AbioCor patient dies, device operation blamed:
This article was originally published in Clinica
Executive Summary
The 13th patient to have received Abiomed's AbioCor heart replacement as part of a trial of the device has died of causes related to the device's operation. The Danvers, Massachusetts firm, which recently submitted a US marketing application for the device, said that together with the US hospital where the implantation was performed, it is investigating the situation and will release a report when an analysis has been completed. The patient had been supported by the device for 147 days. Candidates for the AbioCor clinical trial have a high probability of dying in less than 30 days.