Abbott's Xience Prime nets FDA clearance

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Abbott has received FDA approval for the next-generation Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease.

Xience Prime uses the same drug and biocompatible polymer as the Xience V everolimus-eluting coronary stent system, featuring an updated stent design and a delivery system.

"With Xience Prime, for the first time in the U.S., physicians have a 38 mm everolimus-eluting stent for the treatment of long lesions," Marco A. Costa, MD, PhD, director of the Interventional Cardiovascular Center and director of the Research and Innovation Center at the Harrington-McLaughlin Heart and Vascular Institute at University Hospitals, Case Western Reserve University in Cleveland, and principal investigator of the global SPIRIT PRIME trial, said in a statement.

The updated deliverability and range of sizes, including a small-vessel 2.25 mm diameter stent, will improve the ability to access complex lesions, Costa said.

Xience Prime is based on the stent design of the Multi-Link family, which uses a cobalt chromium technology and includes Vision, Xience V and Promus. In addition, Xience Prime is offered in lengths up to 38 mm.

SPIRIT PRIME is a prospective, two-arm, open-label, multi-center registry designed to evaluate Xience Prime in 500 patients with coronary artery disease. The trial was conducted at more than 60 centers in the U.S. and Australia.

Two registry arms were evaluated: the Core Size arm and the Long Lesion arm. The Core Size arm utilized Xience Prime stents measuring 2.25 mm to 4 mm in diameter and from 8 mm to 28 mm in length. The Long Lesion arm utilized Xience Prime stents measuring 2.5 mm to 4 mm in diameter and either 33 mm or 38 mm in length.

The primary endpoint was target lesion failure at one year, which was a composite of cardiac death, target vessel MI and clinically indicated target lesion revascularization. The full results from the SPIRIT PRIME study will be presented by Costa on Nov. 8, at the 23rd annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.

Xience Prime received CE mark in June 2009.