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FDA approval to Abbott XIENCE nano stent system

The US Food and Drug Administration (FDA) has granted approval to Abbott’s XIENCE nano Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease in small vessels.

The XIENCE family of drug eluting stents is now available in the US in a comprehensive range of diameters from 2.25 mm to 4.0 mm.

XIENCE nano, which features thin struts measuring 0.0032" is based on the same platform as the XIENCE V Everolimus Eluting Coronary Stent System.

It offers physicians in the US a new option for treating patients with coronary artery disease in vessels as small as 2.25 mm in diameter.

The FDA approval of XIENCE nano was supported by results from the SPIRIT Small Vessel clinical trial, which showed very low late loss (a measure of vessel re-narrowing) of 0.20 mm and a target lesion failure (TLF) rate of 8.1%, which is comparable to results observed in the SPIRIT clinical trials with XIENCE V.

Abbott Vascular senior vice president Robert Hance said XIENCE nano leverages the positive safety and efficacy clinical results consistently demonstrated with XIENCE V, which has become the leading drug eluting stent platform worldwide.

Everolimus, developed by Novartis Pharma, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents.

Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.