FDA clears Abbott's smaller Xience DES

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Abbott has received FDA approval for its Xience nano everolimus-eluting coronary stent system for the treatment of coronary artery disease (CAD) in small vessels.

This Xience nano, which is based on the same platform as the Xience V everolimus-eluting coronary stent system, allows U.S. physicians to treat patients with CAD in vessels as small as 2.25 mm in diameter.

The FDA's approval of Xience nano was based on results from the SPIRIT Small Vessel trial, which showed very low late loss of 0.20 mm and a target lesion failure (TLF) rate of 8.1 percent, which is comparable to results observed in the SPIRIT trials with Xience V, according to the Abbott Park, Ill.-based company. TLF is defined as a composite measure of important efficacy and safety outcomes for patients and includes cardiac death, target vessel MI and ischemia-driven target lesion revascularization.

The XIENCE family of drug-eluting stents is now available in the U.S. in a range of diameters from 2.25 mm to 4 mm. Xience nano features struts measuring 0.0032".