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Home Industry News Abbott receives FDA recommendation for Xience V

Abbott receives FDA recommendation for Xience V

30th November 2007

Abbott has announced that the Circulatory System Devices Advisory Panel of the US Food and Drug Administration (FDA) has recommended approval for the Xience V Drug Eluting Stent System.

The FDA committee voted in favour of recommending the Xience V stent system for approval but outlined several conditions.

These conditions related to post-marketing study requirements and language related to dual antiplatelet therapy.

John M Capek, executive vice-president of medical products at Abbott, described the outcome of the advisory committee meeting as “very encouraging”.

“We look forward to bringing this important new treatment for coronary artery disease to physicians and patients in the US,” he added.

Xience V is a drug eluting stent intended for use in the treatment of coronary artery disease.

In June 2007, Abbott filed its pre-marketing approval submission for Xience V to the FDA with data demonstrating its superiority compared to another drug eluting stent.

Gregg W Stone, from the Columbia University Medical Center who led the Spirit III clinical trial, confirmed that the Xience V boasted a robust body of safety and efficacy data and was an important new technology that would enhance the lives of millions of patients with heart disease.

Also this month, Abbott received the annual Illinois Governor’s Pollution Protection Award in recognition of the company’s environmental excellence and its heightened awareness of pollution concerns.

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