(BW)(IN-GUIDANT)(GDT) 盖丹特公司（Guidant）宣布招募首批病人进行世界上首个完全生物可吸收洗脱冠脉支架的临床试验；创新科技可能打开心脏病治疗的新领域
美国商业新闻2006年3月9日印第安纳波利斯和加利福尼亚州圣克拉拉消息—
盖丹特公司（纽约证券交易所：GDT）今日宣布招募首批病人进行一项首次人体临床试验，该临床试验的目的是对使用完全生物可吸收艾罗莫司（everolimus ）洗脱支架平台治疗冠心病的安全性进行评估。这项取名为ABSORB的试验将会在比利时、丹麦、法国、新西兰、波兰和荷兰等国招收多达60例病人。
盖丹特公司血管介入部总裁 John M. Capek博士说：“本次临床试验是世界上首次对完全生物可吸收药物洗脱冠状支架进行评估，这一首次植入将会成为盖丹特公司的重要里程碑。本项研究将为我们今后的研究打下基础，其研究内容是为当前这种在冠状动脉中永久性驻留的药物洗脱支架植入提供一个有价值的备选方案。我们对自身的生物可吸收药物洗脱支架方案感到兴奋，它与盖丹特公司通过生物可吸收性技术提供治疗心脏病的创新性特异位点疗法的策略是一致的。”
ABSORB试验将研究由生物可吸收性解决方案小组开发的生物可吸收性药物洗脱支架的安全性，该小组于2003年在硅谷成立，是盖丹特公司血管介入部的子公司。这些支架可以在冠心病患者的血流恢复和药物洗脱后，被血管组织完全吸收。盖丹特公司针对其生物可吸收支架已完成大量的潜伏期研究，这些研究采集了关于安全性、药物剂量以及支架机械性能的数据。ABSORB临床试验是一项非随机研究，包括6个月的初始安全性评估期（MACE和支架血栓率）以及5年的跟踪期。
首次植入工作由John Ormiston博士和Mark Webster博士领导的小组在新西兰奥克兰城市医院（Auckland City Hospital）进行。鹿特丹（Rotterdam ）伊拉兹马斯大学医院（Erasmus University Hospital）胸腔中心的Ormiston 博士和Patrick Serruys教授将担任这项研究的联合首席研究员。
Ormiston博士说：“随着病人在更复杂的血管解剖中体内冠脉支架的数目不断增加，我们需要能够减少永久性金属支架平台植入数量，并能在对患者持续一段时间的追踪和治疗方面提供更强灵活性的临床解决方案。迄今为止，盖丹特公司在生物可吸收技术方面的进步让我们深受鼓舞，我们期待着更深地探索这项技术的潜力，这也是ABSORB试验的一部分。”
盖丹特公司在心血管疾病治疗方面处于世界领先地位。该公司是救生技术的先锋企业，并为世界范围内数百万心血管疾病患者带来了福音。盖丹特开发、制造和销售一系列可以减少对一些濒危患者侵入性治疗的产品和服务。更多信息请访问 www.guidant.com 。
媒体注意：关于盖丹特公司的更多信息，包括其产品和服务，请访问公司网站新闻阅览室（newsroom）www.guidant.com/newsroom 。
这篇报道包含了前瞻性声明。此类前瞻性声明是基于对很多重要因素的假设作出的，其中包括公司对即将从试验中得到的临床数据的预期，以及可从公司10-K表格中最近文件的1A项里查到的其他因素。实际结果可能与之存在重大差异。公司不承担更新其前瞻性声明的责任。
联系方式：盖丹特公司 公共关系部 Steven Tragash, 317-971-2031 或者 盖丹特公司 投资者关系部 Doug Hughes, 317-971-2039 Andy Rieth, 317-971-2061
(BW)(IN-GUIDANT)(GDT) Guidant Announces Enrollment of First Patient in Clinical Trial of the World's First Fully Bioabsorbable Drug Eluting Coronary Stent; Innovative Technology Could Represent New Frontier in the Treatment of Heart Disease
INDIANAPOLIS & SANTA CLARA, Calif.--(BUSINESS WIRE)--March 9, 2006--
Guidant Corporation (NYSE:GDT) today announced enrollment of the first patient in a first-in-man clinical trial designed to evaluate the safety of a fully bioabsorbable everolimus eluting stent platform for the treatment of coronary artery disease. The trial, called ABSORB, will enroll up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands.
"As the world's first clinical trial evaluating a fully bioabsorbable drug eluting coronary stent, this initial implant marks a significant milestone for Guidant. This study will lay the foundation for our continued work toward offering a valuable alternative to current drug eluting stent implants that reside permanently in the treated coronary artery," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "We are excited about our bioabsorbable drug eluting stent program, which is aligned with Guidant's strategy of leveraging bioabsorbable technologies to provide innovative site-specific therapy for the treatment of heart disease."
The ABSORB trial will study the safety of bioabsorbable drug eluting stents developed by Bioabsorbable Vascular Solutions, an entrepreneurial subsidiary of Guidant Vascular Intervention established in 2003 in the Silicon Valley. These stents are designed to be fully absorbed by vascular tissue following the restoration of blood flow and drug elution in patients with coronary artery disease.
Guidant has completed extensive preclinical studies on its bioabsorbable stent, gathering data on safety, drug dosing, and the mechanical properties of the stent. The ABSORB clinical trial is a non-randomized study with an initial assessment of safety (MACE and stent thrombosis rate) at six months and a follow-up period of five years.
The first implant was performed by a team headed by Drs. John Ormiston and Mark Webster at Auckland City Hospital, New Zealand. Dr.Ormiston and Professor Patrick Serruys, of the Thoraxcenter, Erasmus University Hospital, Rotterdam will serve as the study's co-principal investigators.
"With patients receiving an ever-increasing number of coronary stents in more challenging vessel anatomies, we need clinical solutions that reduce the amount of permanent metallic stent platforms being implanted, and provide for increased flexibility in monitoring and treating patients over an extended period of time," said Dr.Ormiston. "We are highly encouraged by the progress thus far with Guidant's bioabsorbable technology, and look forward to further exploring its potential as part of the ABSORB trial."
Guidant Corporation is a world leader in the treatment of cardiac and vascular disease. The company pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. Guidant develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information visit www.guidant.com.
NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom.
This release includes forward-looking statements. The statements are based on assumptions about many important factors, including the company's expectations concerning the clinical data that will result from the trial, and other factors identified in Item 1A of the company's most recent filing on Form 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements.
CONTACT: Guidant Corporation Corporate Communications Steven Tragash, 317-971-2031 or Guidant Corporation Investor Relations Doug Hughes, 317-971-2039 Andy Rieth, 317-971-2061