Abbott announced on 14 September 2009 that the Chinese State Food and Drug Administration has approved its Xience V Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease – the leading cause of death in China.
Xience V is the only drug-eluting stent to have demonstrated superiority over the Taxus Paclitaxel-Eluting Coronary Stent System in the primary endpoints of two randomised, pivotal (phase III) clinical trials. The company plans a fourth-quarter launch for Xience V in China, which is the second-largest drug-eluting stent market in the Asia-Pacific region after Japan. 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.
According to the China Chronic Heart Disease 2006 Annual Report, nearly 50% of all deaths annually in China are due to coronary artery disease, and the prevalence of coronary artery disease has steadily increased each year. Approximately 150,000 patients annually undergo a stent procedure for the treatment of coronary artery disease, and the number of procedures is growing by more than 20% each year in China.
“Heart disease is a serious health issue in China, with more patients being diagnosed each day, so it is critical to have access to advanced technology, such as Xience V, that can help improve patient outcomes,” said Run Lin Gao, vice president, Chinese Medical Doctor Association.
“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,” said Yong Huo, president-elect, Chinese Society of Cardiology.