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VeriFlex stent

This article was originally published in The Gray Sheet

Executive Summary

An item in FDA's Feb. 17 public listing of device recalls drew attention to Boston Scientific's recent move to rename its Taxus Liberté bare-metal coronary stent VeriFlex Bare-Metal. After hearing from cardiac cath labs that health care providers were inadvertently selecting Liberté bare-metal stents when the interventional cardiologist intended to implant a Liberté drug-eluting stent and vice-versa, the firm decided to rename the bare-metal version. In the recall, initiated last September, company reps visited all affected health care facilities and re-labeled the outer boxes of Liberté bare-metal stents to reflect the new name. The same month, FDA approved Boston Scientific's PMA supplement seeking to use the new trade name (1"The Gray Sheet" Nov. 2, 2009). Liberté paclitaxel-eluting stents continue to go by their original name

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