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Abbott's Xience V stent approved by FDA
03 Jul 2008
Abbott says its Xience V stent has been approved by the US Food and Drug Administration for the treatment of coronary heart disease.
The company reports the drug-coated stent is used to prop open narrow or blocked arteries while releasing the drug everolimus, which further prevents re-blocking of the artery after a stent procedure.
According to Abbott, Xience V is the only drug-eluting stent to have "demonstrated superiority over Boston Scientific's Taxus paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials".
John M Capek, the company's executive vice-president for Medical Devices, believes the drug will rapidly become the new standard for drug-eluting stents.
Gregg W Stone, principal investigator of the Spirit III US clinical trial for Xience V, says the results confirm the drug is a "true next-generation drug-eluting stent".
Abbot has said it will announce its second-quarter financial results on July 16th, which will be immediately followed by a live webcast conference call available on its investor relations website.