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Abiomed gets US nod to continue AbioCor trial:

This article was originally published in Clinica

Executive Summary

Abiomed is pressing on with a clinical trial of its implantable replacement heart, AbioCor, after gaining permission from the US FDA to implant the device in another five patients. The trial will consist of a total of 15 patients, who will be assessed in groups of five. The FDA's decision comes shortly after the first patient enrolled in the trial suffered a stroke (see Clinica No 984, p 20). While noting that it has much to prove and learn, the Danvers, Massachusetts firm says that clinical results from the first five patients implanted with the device look "extremely promising".





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