FDA Expands Xience Stents’ Indication for Coronary Chronic Total Occlusions

November 4, 2014 — The U.S. Food and Drug Administration (FDA) has cleared the Abbott family of Xience everolimus-eluting coronary stents for the additional indication to treat coronary chronic total occlusions (CTOs).

The expanded indication includes the Xience V, Xience nano, Xience Prime, Xience Xpedition, and Xience Alpine stent systems.

In addition to the usual post-approval annual report requirements, Abbott must provide the following data in a separate post-approval study (PAS) report: The Extended Follow-up of the EXPERT CTO Study will continue the follow-up of 205 patients available at one year from the premarket cohort (EXPERT CTO trial). This is a prospective, multi-center study and all available patients will be followed out to five years post-procedure.

For more information: www.accessdata.fda.gov