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January 3, 2013

FDA approves Abbott drug eluting stent for symptomatic heart disease treatment

The US Food and Drug Administration (FDA) has approved Abbott's drug eluting stent system, which is designed to improve coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions.

By admin-demo

The US Food and Drug Administration (FDA) has approved Abbott’s drug eluting stent system, which is designed to improve coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The Xience Xpedition Everolimus Eluting Coronary Stent system, which will be available in rapid exchange (RX) and over-the-wire (OTW) configurations, has proven to be safe for direct stenting, which does not require another device such as a balloon dilatation catheter to prepare the lesion.

Featuring a new stent delivery system, the system has diameter ranging from 2.25mm to 4mm, including a unique 3.25mm diameter, and lengths from 8mm to 38mm, for more accurate vessel sizing.

The approval 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 has consistently shown an excellent safety profile for the Xience family of stents, according to the company.

Abbott medical devices executive vice president John Capek said; "Xience Xpedition leverages the strong clinical outcomes of Xience V and Xience Prime while providing important advantages in deliverability."

Mount Sinai Medical Center Clinical and Interventional Cardiology director, International Clinical Affiliations dean and Mount Sinai Heart Network president Dr Samin Sharma said; "Xience Xpedition represents a powerful combination of deliverability, strong clinical data and broad availability of meaningful sizes – three factors that make this product well-suited to treat a wide range of patients."

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