Abbott Xact carotid stent
This article was originally published in The Gray Sheet
Executive Summary
Firm anticipates debut of stent with Emboshield embolic protection system by June, following receipt of an "approvable" letter from FDA and a planned inspection. Guidant was first to gain carotid stent/embolic protection system approval last August (Rx Acculink/Rx Accunet ). J&J/Cordis also is awaiting final go-ahead after receiving an August 2004 approvable letter for Precise/AngioGuard XP (1"The Gray Sheet" Sept. 6 2004, p. 3)...