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.