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Abiomed receives Impella Class III blow, but might escape cost of new trial

This article was originally published in Clinica

Executive Summary

An FDA advisory panel has recommended Class III designation for Abiomed's Impella 2.5 heart pump, as predicted. However, even though the device looks likely to now be regulated under premarket approval (PMA) rather than 510(k) regulations, the company may have got off relatively lightly: it may not necessarily need to conduct a new clinical trial, according to Morgan Stanley analyst David Lewis.

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