Abbott Laboratories has announced that the XIENCE Xpedition Everolimus Eluting Coronary Stent System has received FDA approval.
XIENCE Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies.
Abbott's XIENCE drug eluting stents, including XIENCE Xpedition, are the drug eluting stents in the US market which are proven safe for direct stenting. Direct stenting, a technique in which the stent system is not preceded by another device (such as a balloon dilatation catheter) to prepare the lesion, has the potential to save time and resources in the catheterization laboratory.
XIENCE Xpedition is supported by clinical evidence from the XIENCE family of drug eluting stents, including data from more than 45,000 patients across more than 100 studies, with long-term outcomes out to five years. Data have consistently shown an excellent safety profile for the XIENCE family of stents.
"The launch of XIENCE Xpedition in the US will advance Abbott's worldwide market-leading position in drug eluting stents," said John Capek, executive vice president, Medical Devices, Abbott.
"XIENCE Xpedition leverages the strong clinical outcomes of XIENCE V and XIENCE PRIME while providing important advantages in deliverability. With its redesigned stent delivery system and a full matrix of sizes, XIENCE Xpedition provides physicians with a comprehensive, trusted option to treat a broad range of patients with coronary artery disease."