Boston Scientific Welcomes FDA Panel Recommendation for PROMUS / XIENCE V
December 6, 2007 - Boston Scientific Corp. welcomed the recommendation of a FDA advisory panel to approve with conditions the PROMUS/ XIENCE V everolimus-eluting coronary stent system, marking a significant step toward making Boston Scientific's two-drug program a reality in the U.S.
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.
"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,” said Hank Kucheman, senior vice president and president of Boston Scientific’s Cardiovascular business.
The PROMUS and XIENCE V stent systems are investigational devices in the U.S. and not yet approved for sale. PROMUS is a private-labeled XIENCE V everolimus-eluting stent system manufactured by Abbott and distributed by Boston Scientific.
TAXUS and PROMUS are trademarks of Boston Scientific Corp. or its affiliates. XIENCE is a trademark of the Abbott Laboratories group of companies.
For more information: www.bostonscientific.com
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