Abbott’s Xience family of stents received U.S. Food and Drug Administration approval for one-month (as short as 28 days) dual anti-platelet therapy labeling for high bleeding risk patients in the United States.
The U.S. FDA’s Circulatory System Devices Panel is undergoing two days of presentations and meetings regarding mortality rates associated with the use of paclitaxel-coated balloons and paclitaxel-eluting stents.
Abbott received approval from the U.S. Food and Drug Administration for XIENCE Sierra, the newest generation of the gold-standard XIENCE everolimus-eluting coronary stent system.