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Abbott XIENCE Xpedition DES Wins FDA Green Light

January 3rd, 2013 Medgadget Editors Cardiology, Vascular Surgery

The new Abbott received FDA clearance for its XIENCE Xpedition drug eluting coronary stent that is delivered directly without having to use a dilation balloon. It is built to be able to traverse through narrow vessels without exchanging instruments in preparation for deployment.

Last year XIENCE Xpedition was launched in Europe and has seen use in thousands of cases already.

Abbott’s XIENCE drug eluting stents, including the newly approved XIENCE Xpedition, are the first and only drug eluting stents in the U.S. market to be 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 robust 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.

XIENCE Xpedition will be available in the largest size matrix in the U.S. market, with both rapid exchange (RX) and over-the-wire (OTW) configurations, providing physicians with the most popular delivery platforms. XIENCE Xpedition has diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and lengths from 8 mm to 38 mm, for more accurate vessel sizing.

Product page: XIENCE Xpedition…

Press release: Abbott Announces FDA Approval and U.S. Launch of Next-Generation XIENCE Xpedition™ Drug Eluting Stent System

Flashback: Abbott XIENCE Xpedition Coronary Drug Eluting Stent Now Available in Europe

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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