SFDA Approves Abbott’s XIENCE V Drug Eluting Stent

The Chinese State Food and Drug Administration (SFDA) has approved Abbott’s XIENCE V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD)

The company plans a fourth-quarter launch for XIENCE V in China. With approval in China, XIENCE V is now available in every Asia-Pacific market except Japan, where approval is anticipated at the end of this year.

Yong Huo, president-elect at Chinese Society of Cardiology, said: “Clinical trial results show that XIENCE V has a strong safety and efficacy profile, with impressively low rates of major adverse cardiac events and target vessel failure. Based on the strength of the data supporting it, XIENCE V is a welcome addition to the heart disease treatment options available to physicians in China.”