大连垠艺冠脉支架要素.pptVIP

大连垠艺生物材料研制开发有限公司 DALIAN YINYI BIOMATERIALS DEVELOPMENT CO., LTD. 新一代载药技术，更安全的选择 New Generation Technology，Your Safer Choice 垠艺TM紫杉醇微孔载药冠状动脉支架系统 大连垠艺生物材料研制开发有限公司 DALIAN YINYI BIOMATERIALS DEVELOPMENT CO., LTD. 药物涂层支架的发展趋势 聚合物涂层支架 可降解涂层支架 无涂层药物支架 可降解药物支架 第一代DES Cypher Taxus Endeavor Firebird Partner …… 第二代DES 垠艺TM 第三代DES ？？ 改良的第一代DES Excel 爱克赛尔 大连垠艺生物材料研制开发有限公司 DALIAN YINYI BIOMATERIALS DEVELOPMENT CO., LTD. 第一代药物涂层支架的作用 金属支架 多聚体涂层 药物 抑制平滑肌细胞增生 促进内皮细胞生长 抑制炎性反应 药物载体、控制释放 机械性压迫斑块 机械性支撑血管 大连垠艺生物材料研制开发有限公司 DALIAN YINYI BIOMATERIALS DEVELOPMENT CO., LTD. 第一代药物涂层支架的长期状况 金属支架 多聚体涂层 药物 100%代谢，无残留 无作用 永久存在 机械性支撑 永久存在 FDA News FOR IMMEDIATE RELEASEP03-50July 8, 2003 Media Inquiries: 301-827-6242Consumer Inquiries: 888-INFO-FDA Cordis Corporation Issues a Health Care Professional Letter Regarding the CYPHER Stent Cordis Corporation (Cordis) has issued the attached letter to health care professionals to inform them of the rare but potential risk of thrombosis associated with the use of its product the CYPHER Sirolimus-Eluting Coronary Stent (CYPHER stent). This letter also provides clarification on the safe use of the product in accordance with the scientific evidence that led to product approval. The CYPHER stent was approved in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. Since the product’s introduction it is estimated that over 50,000 patients have received a CYPHER stent. To date, FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation. The Food and Drug Administration (FDA) is carefully reviewing the reports of adverse events and is working closely with the company to determine the exact causes and reduce the incidence of thrombosis. From the reports received so far, it is unclear what effect the CYPHER stent has on thrombosis risk and what factors may contribute to the risk. As part of the approval for this product, FDA required Cordi