News | January 07, 2010

Everolimus-Eluting Stents Gain Japanese Clearance

The XIENCE V gained regulatory approval in Japan.

January 8, 2010 – Japanese regulatory officials this week cleared the XIENCE V Everolimus-Eluting Coronary Stent. Abbott said it plans to launch sales in Japan in the coming weeks, immediately following final reimbursement authorization.

The approval also cleared the way for Boston Scientific’s PROMUS Everolimus-Eluting Stent, which is the XIENCE V stent sold under a different name. Boston and Abbott have a distribution agreement as part of a deal executed prior to Boston’s 2006 acquisition of the former Guidant Corp., where the stent’s technology originated.

Japan is the second largest drug-eluting stent market in the world after the United States, with approximately 200,000 stent procedures performed each year.

"XIENCE V is flexible and easy to deliver through the coronary anatomy to the lesion site. These attributes combined with the strength of the safety and efficacy data supporting it give me confidence that XIENCE V is a true next-generation stent that has the potential to benefit heart patients in Japan," said Shigeru Saito, M.D., FACC, FSCAI, FJCC, director, cardiology and catheterization laboratories, Shonan Kamakura General Hospital, and principal investigator for the Xience SPIRIT III Japan Registry.

The XIENCE V received CE mark approval in 2006 and FDA clearance in 2008.

For more information: www.abbott.com, www.bostonscientific.com

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