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News

Promus/ Xience V everolimus-eluting coronary stent system receives US FDA approval

Boston Scientific : 30 November, 2007  (New Product)
Boston Scientific has welcomed a US Food and Drug Administration (FDA) advisory panel's recommendation to approve with conditions the Promus/ Xience V everolimus-eluting coronary stent system.
The Promus and Xience V Stent systems are identical products, sold respectively by Boston Scientific and Abbott in international markets. Both Stent systems would be covered by the same FDA approval.

'Today's recommendation is a significant step toward making Boston Scientific's two-drug program a reality in the United States,' said Hank Kucheman, Senior vice president and president of Boston Scientific's Cardiovascular business. 'Once approved in the United States, the Promus Stent system - together with our proven and market-leading Taxus Stent technology - will enable Boston Scientific to offer physicians and their patients a choice of two distinct drugs, each on a highly deliverable Stent platform.'

The Promus and Xience V Stent systems are investigational devices in the USA and not yet approved for sale. Promus is a private-labelled Xience V everolimus-eluting Stent system manufactured by Abbott and distributed by Boston Scientific.


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