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Panel Advises 5,000-Patient Postmarket Study For Medtronic’s DES

This article was originally published in The Gray Sheet

Executive Summary

Medtronic should conduct a large postmarket study to monitor late stent thrombosis and help define the appropriate antiplatelet drug regimen for drug-eluting stent patients, FDA's Circulatory System Devices Panel recommended at its Oct. 10 meeting in Gaithersburg, Md

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