Japan Approves Abbott Vascular's Xience V DES and Boston Scientific's Promus DES

January 8, 2010—Abbott Vascular (Santa Clara, CA) announced that the Japanese Ministry of Health, Labor and Welfare has approved its Xience V everolimus-eluting coronary stent system for the treatment of coronary artery disease. The company stated that it will launch Xience V in Japan immediately following final reimbursement authorization, which is expected in the coming weeks.

Abbott Vascular noted that in some commercial markets, the company supplies an identical private-label version of Xience V to Boston Scientific Corporation (Natick, MA) that is marketed as the Promus everolimus-eluting coronary stent system. Promus is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies. Boston Scientific also announced the Japanese approval of Promus for the treatment of coronary artery disease and the launch of the device pending reimbursement approval.

The Xience V and Promus devices are indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (up to 28 mm long) with reference vessel diameters of 2.5 to 3.75 mm.

According to Abbott Vascular, the approval was supported by data demonstrating the Xience V’s long-term efficacy and safety results in the primary endpoints of the pivotal trials and among the SPIRIT family of trials. The SPIRIT III Japan Registry of 88 patients demonstrated similar angiographic and clinical results to the outstanding outcomes from the SPIRIT III trial in the United States. In the SPIRIT III Japan Registry, XIENCE V demonstrated an 8% rate of major adverse cardiac events and no cases of stent thrombosis out to 1 year. Shigeru Saito, MD, was the principal investigator for the SPIRIT III Japan Registry.