Boston Sci, Abbott DES gain Japanese approval

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Boston Scientific's Promus and Abbott's Xience V, two everolimus-eluting coronary stent systems used to treat coronary artery disease, have received approval from the Japanese Ministry of Health, Labor and Welfare for marketing and distribution rights throughout Japan.

Boston Scientific and Abbott Laboratories entered into an agreement prior to the 2006 acquisition of Guidant by Boston Scientific for distribution of the Promus and Xience V stents—identical products sold by the companies under different brand names.

According to the Natick, Mass.-Boston Scientific and Abbott, Ill.-based Abbott, the stent, made of cobalt chromium, has been indicated for progressing coronary luminal diameter in symptomatic heart disease patients caused by de novo native coronary artery lesions of up to 28 mm long with a reference vessel diameter of 2.5 to 3.75 mm.

According to Abbott, Japan has the second largest drug-eluting stent market behind the U.S., with almost 200,000 stent procedures performed per year.

In a SPIRIT III clinical trial of 88 patients, Xience V was illustrated to be safe and effective for patients with coronary artery disease, according to Abbott. Results showed single-digit rates of adverse cardiac events, such as cardiac death, heart attack or ischemia-driven target lesion revascularization and no cases of stent thrombosis.

According to the companies, distribution is set to commence in the upcoming weeks after the companies gain product reimbursement approval.