J&J GATHERING STRESS, BENESTENT TRIAL DATA FOR FDA SUBMISSION
This article was originally published in The Gray Sheet
Executive Summary
J&J GATHERING STRESS, BENESTENT TRIAL DATA FOR FDA SUBMISSION in support of its premarket approval application for the Palmaz- Schatz coronary stent. In December, FDA's circulatory system devices panel recommended against approval of the stent due to the inadequacy of Johnson & Johnson Interventional Systems' nonrandomized clinical trial ("The Gray Sheet" Dec. 20, 1993, p. 3). However, the panel suggested that the Stent Restenosis Study (STRESS) and the Benestent trial might provide sufficient data for approval.