FDA clarifies DES reports
This article was originally published in The Gray Sheet
Executive Summary
Updated 1public health notification on J&J/Cordis' Cypher drug-eluting stent, issued by FDA Nov. 25, follows reports from physicians and Cordis reps maintaining that an earlier, Oct. 10 notice misled the public about safety concerns related to thrombosis and hypersensitivity (2"The Gray Sheet" Nov. 3, 2003, p. 4). "We consider the Cypher stent a safe and effective product when used according to the labeling, particularly concerning patient selection and appropriate peri-procedural medication," FDA clarifies...