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Enteryx labeling change

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific plans to amend the approved labeling for its Enteryx esophageal gastric reflux suppression device to emphasize proper implantation technique and clarify possible complications related to improper technique, according to the firm. The changes were triggered by the recent death of an Enteryx recipient from a ruptured aorta. FDA currently is investigating the incident. Boston Scientific attributes the event to operator error...

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