FDA 顾问委员会建议批准XIENCE™ V药物洗脱支架系统上市

FDA Advisory Committee Recommends Approval of Abbott’s XIENCE™ V Drug Eluting Stent System

　　雅培公司（ABBOTT）于2007年11月29日宣布：FDA循环系统器械顾问委员会推荐依维莫司冠脉洗脱支架系统XIENCE™ V获得批准。XIENCE V是治疗冠状动脉疾病的新一代药物洗脱支架。

　　在上市后继续进行研究和使用双重抗血小板治疗的条件下，FDA顾问委员会投票推荐核准XIENCE V支架系统上市。虽然没有要求FDA必须通过，但FDA通常会遵循顾问委员会的建议。
 
　　来自哥伦比亚大学医学中心及心血管研究机构（CRF），SPIRIT III 临床试验的主要负责人Gregg W. Stone, M.D说：“经SPIRIT系列试验证实，XIENCE V支架与美国最普遍应用的药物洗脱支架相比，其临床结果和血管造影结果的获益具有一致性和显著性。这些安全性及有效性的数据将有力地证实，批准XIENCE V作为一个重要的新技术将能挽救数百万心脏病患者的生命。

　　2007年6月1日，雅培公司向FDA提交了XIENCE V上市前批件（PMA）的申报资料。PMA申报资料中提交的数据首次通过头对头的随机对照试验证实，在其主要研究终点节段内晚期管腔丢失方面，一个药物支架优于另一个药物支架，且后者在市场占有率上居于领先地位。

　　雅培医疗产品部执行副总裁，John M. Capek, Ph.D.说：“今天顾问委员会的会议结果非常振奋人心。我们期待着将这项重要的治疗冠状动脉疾病的新方法介绍给美国的内科医生和患者。”

　　XIENCE V是在2006年投放欧洲市场和其他国际市场的。XIENCE V目前在美国和日本属于研究器械（尚未上市）。

　　关于雅培

　　雅培是全球多元化的医疗保健产品公司，致力于研发、生产和销售涵盖营养、器械和诊断的药物和医疗产品。公司拥有65,000名员工，其产品在为130多个国家的患者服务。

　　获得雅培的新闻发布和其他的信息可登录网站：www.abbott.com

　　（来源：雅培公司）

FDA Advisory Committee Recommends Approval of Abbott’s XIENCE™ V Drug Eluting Stent System

ABBOTT PARK, Ill., Nov. 29, 2007 — Abbott announced today that the Circulatory System Devices Advisory Panel to the U.S. Food and Drug Administration (FDA) recommended approval for the XIENCE™ V Everolimus Eluting Coronary Stent System..XIENCE V is a next-generation drug eluting stent intended for use in the treatment of coronary artery disease.

The FDA advisory committee voted to recommend the XIENCE V stent system for approval with conditions related to post-marketing study requirements and language related to dual antiplatelet therapy. The FDA is not required to, but usually follows the recommendations of its advisory committees.

"The clinical and angiographic benefits of the XIENCE V stent compared to the most widely used drug eluting stent available in the U.S. have been consistent and significant across the SPIRIT trials,"said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York and principal investigator of the SPIRIT III clinical trial. “The robust body of safety and efficacy data support approval of XIENCE V as an important new technology that will enhance the lives of millions of patients with heart disease.”

Abbott filed its Premarket Approval (PMA) submission for XIENCE V with the FDA on June 1,2007. The PMA for XIENCE V is the first to include data demonstrating superiority of one drug eluting stent over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market leading product.

"The outcome of today’s advisory committee meeting is very encouraging,” said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. “We look forward to bringing this important new treatment for coronary artery disease to physicians and patients in the U.S.”

XIENCE V was launched in Europe and other international markets in 2006. XIENCE V is currently an investigational device in the United States and Japan.

About Abbott Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

Abbott’s news releases and other information are available on the company’s Web site at www.abbott.com