Japan OKs Abbott Stent System for Coronary Artery Disease

The Japanese Ministry of Health, Labor and Welfare has approved Abbott Laboratories’ XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease, according to the Abbott Park, Ill.-based firm.

The company, which manufactures cardiac and vascular devices, plans to launch XIENCE V in Japan in the upcoming weeks, immediately following final reimbursement authorization, according to a statement.

The XIENCE V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug everolimus in a controlled manner to prevent the artery from blocking again following a stent procedure.

“Each aspect of XIENCE V’s design, from the thin struts to the flexible delivery system to the drug and polymer, was carefully engineered for optimal deliverability and to improve safety and efficacy outcomes for patients compared to earlier generation stents. These attributes have made XIENCE V the market-leading drug eluting stent around the world, and we look forward to making XIENCE V available to physicians in Japan shortly,” said Robert Hance, senior vice president, Vascular, Abbott.

Shigeru Saito, director, Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital in Kamakura, Kanagawa, and principal investigator for the SPIRIT III Japan Registry said, “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.”