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Thoratec seeks broader indication for VAD (ventricular assist device) System

This article was originally published in Clinica

Executive Summary

Thoratec Laboratories says it has received a favourable initial response from the FDA in its efforts to gain approval to use its ventricular assist device (VAD) system for the reversal of late-stage heart failure. The company has filed a pre-PMA supplement, which allows it to maintain an informal dialogue with the agency prior to submitting a full PMA supplement application.

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