Chinese SFDA approves Abbott's XIENCE V drug eluting stent for treating coronary artery disease

Sep 14 2009

Abbott (NYSE: ABT) announced today that the Chinese State Food and Drug Administration (SFDA) has approved its XIENCE V(R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD) - the leading cause of death in China. XIENCE V is the only drug eluting stent to have demonstrated superiority over the TAXUS(R) Paclitaxel-Eluting Coronary Stent System (TAXUS) in the primary endpoints of two randomized, 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.

"Since it first became commercially available in 2006, XIENCE V has become the market-leading drug eluting stent around the world due to its excellent outcomes and outstanding deliverability," said Robert Hance, senior vice president, vascular, Abbott. "As the incidence of heart disease and the number of annual stent procedures continue to increase in China, it is critical for physicians and patients to have access to one of the most advanced drug eluting stent technologies. We look forward to making XIENCE V available in China."

According to the China Chronic Heart Disease 2006 Annual Report, nearly 50 percent of all deaths annually in China are due to CAD, 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 CAD, and the number of procedures is growing by more than 20 percent 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, M.D., 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, M.D., president-elect, Chinese Society of Cardiology.