Abbott has obtained regulatory approval for its XIENCE Xpedition Everolimus Eluting Coronary Stent system, designed for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions, from the US Food and Drug Administration (FDA).
The drug eluting system 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 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and lengths from 8 mm to 38 mm, for more accurate vessel sizing.
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 have 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."
Clinical and Interventional Cardiology director International Clinical Affiliations dean 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."