美通社/雅培（纽约证券交易所，雅培）宣布XIENCE SierraTM已获得美国食品药品监督管理局的批准，它是该公司黄金标准XIENCE依维莫司洗脱冠状支架系统的最新一代产品。XIENCE支架是世界上使用范围最广且被研究次数最多的支架之一，安全性能卓越，出现并发症的几率极低。这一代XIENCE产品在设计和技术上都做出了改善，例如为了治疗复杂堵塞而专门设计的特性，目前复杂堵塞占总案例的比例高达70%。1

“我们开发出了XIENCE Sierra，有了它，即使在极具挑战性的案例中，医生也可以更加轻松地递送支架"，雅培心血管业务高级副总裁Chuck Brynelsen说道。新颖的设计以及改善的递送性使得医生能够以比其他支架更灵活更准确的方式接触并解决那些难治性病变"

XIENCE Sierra在设计方面也做了一些创新，包括更轻薄的外形，更高的灵活性，更长的长度以及更小的半径。新的支架以及递送系统专门用于治疗复杂案例，包括多血管堵塞患者或血管全部堵塞患者。

自2006年在欧盟以及2008年在美国首次获得监管批准以来，目前全球已经有8百万人接受了XIENCE支架植入。它无与伦比的安全特性得到了100多项临床试验和10年全球实际经验的支持。2

雅培于2018年4月在日本获得XIENCE Sierra的监管批准，并于2017年10月在欧洲获得CE标志认可。

关于冠状动脉疾病：

当向心脏供血的动脉变得坚硬狭窄时，便会发生冠状动脉疾病，导致胸痛或气短，并增加心脏病发作的风险。要想治疗冠状动脉疾病，介入心血管专家可以行经皮冠脉介入，这是一种非手术疗法，通过腿部或腕部的动脉插入导管，然后用导管植入支架，以便重新打开血管并使血液恢复流动。

关于XIENCE：

 

XIENCE于2006年首次获得CE标志认可，并于2008年首次获得FDA批准。其安全特性无可匹敌，即使在复杂案例中，支架内血栓形成的几率也始终保持在较低水平3,4。XIENCE上的特殊涂层会与血液中的蛋白质相互作用，降低支架内血栓的风险。XIENCE Sierra支架是用导管植入的，而导管则是通过腹股沟的股动脉或腕部的桡动脉插入的。

参考：

1 决策资源组, 2017年7月.雅培归档数据.

2 10,000,000的植入数量是基于2017年第一季度的DES植入数据得出的。基于美国、日本、中国、印度、西欧前五个国家和韩国的单位使用量的相对债权. 其他领先DES：BSX支架（Promus Element、Promus Element Plus、Promus Premier、Synergy）；MDT支架（Resolute、Resolute Integrity、Resolute Onyx）；Terumo支架（Nobori、Ultimaster）；Biotronik支架（Orsiro）；以及Biosensors支架（BioMatrix）. 雅培心血管归档数据.  

3 Palmerini等. 与多个大型荟萃分析和其他随机临床试验中的若干个DES和复合BMS相比，XIENCE获益显著. 柳叶刀杂志. 379:9824, 2012年4月14-20日, pp. 1393-1402；Bangalore S等. 循环：心血管介入, 2013年8月6日. doi: 10.1161/ 循环介入.113.000415.; Valgimigli等. 钴铬依维莫司洗脱或裸金属支架对致死性和非致死性心血管事件的效果. 患者水平的荟萃分析. EuroPCR 2014；Serruys, PW等. RESOLUTE All Comers Trial, NEJM 2010. 线上发表于2010年6月16日；Fajadet, J.等. PLATINUM PLUS 30-day Poster, TCT 2012.

4 与多个大型荟萃分析和其他随机临床试验中的若干个DES和复合BMS相比，XIENCE获益显著. Palmerini等. 柳叶刀杂志. 379:9824, 2012年4月14-20日, pp. 1393-1402；Bangalore S等. 循环：心血管介入, 2013年8月6日. doi: 10.1161/ 循环介入.113.000415.; Valgimigli, 钴铬依维莫司洗脱或裸金属支架对致死性和非致死性心血管事件的效果. 患者水平的荟萃分析. EuroPCR 2014; Serruys, PW等. RESOLUTE All Comers Trial, NEJM 2010. 线上发表于2010年6月16日； Fajadet, J.等. PLATINUM PLUS 30-day Poster, TCT 2012.

消息原文：

NEWEST GENERATION OF LEADING HEART STENT IS NOW APPROVED IN THE U.S. FOR PEOPLE WITH CORONARY ARTERY DISEASE

- XIENCE Sierra™, the newest generation of XIENCE drug-eluting stents, received U.S. Food and Drug Administration (FDA) approval

- XIENCE stents are among the most-widely used and studied stents in the world and have an unparalleled safety record

- New features help doctors treat more difficult-to-reach blockages in patients' arteries

May 23, 2018 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for XIENCE SierraTM, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. XIENCE stents are among the world's most-used and studied stents and have an exceptional safety record with low rates of complications. Design and technology advances in this generation of XIENCE include features specifically designed for the treatment of complex blockages that now account for up to 70 percent of cases.1

"We developed XIENCE Sierra so that physicians can more easily deliver the stent even in challenging cases," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents."

Design innovations in XIENCE Sierra include a thinner profile, increased flexibility, longer lengths, and small diameters. The new stent and delivery system were specifically developed for the treatment of complex cases, including people with multiple or totally blocked vessels.

More than 8 million people worldwide have received a XIENCE stent since its initial regulatory approvals in the EU in 2006 and in the U.S. in 2008. Its unparalleled safety is supported in over 100 clinical trials and by 10 years of global real-world experience.2

Abbott received Regulatory approval for XIENCE Sierra in Japan in April 2018, and CE Mark in Europe in October 2017.

About Coronary Artery Disease:

Coronary artery disease occurs when the arteries that supply blood to the heart become hard and narrow, leading to chest pain or shortness of breath and increased risk of heart attack. To treat coronary artery disease, interventional cardiologists may perform a percutaneous coronary intervention, a non-surgical procedure that uses a catheter inserted through an artery in the leg or wrist to implant a stent that reopens vessels and allow blood to flow.

About XIENCE:

XIENCE first received CE Mark in 2006 and FDA approval in 2008. Its safety profile is unparalleled with consistent low rates of stent thrombosis, even in complex cases.3,4 A special coating on XIENCE interacts with proteins in the blood to reduce the risk for blood clots in the stent. The XIENCE Sierra stent is implanted using a catheter that is inserted through the femoral artery in the groin or radial artery in the wrist. 

1 Decision Resources Group, July 2017. Data on file at Abbott.

2 10,000,000 implants number is based on data of DES implants through Q1 2017. Comparative claim based on unit usage in U.S., Japan, China, India, top 5 Western Europe, and Korea. Other leading DES: BSX stents (Promus Element, Promus Element Plus, Promus Premier, Synergy); MDT stents (Resolute, Resolute Integrity, Resolute Onyx); Terumo stents (Nobori, Ultimaster); Biotronik stent (Orsiro); and Biosensors stent (BioMatrix). Data on file at Abbott Vascular.  

3 Palmerini, et al. XIENCE showed significant benefit compared to several DES and composite BMS in multiple large scale meta-analyses and other RCTs. The Lancet. 379:9824, 14-20 April 2012, pp. 1393-1402; Bangalore S, et al. Circ Cardiovasc Interv, Aug 6, 2013. doi: 10.1161/ circinterventions.113.000415.; Valgimigli, et al. Effects of Cobalt-chromium Everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events. A patient-level meta analysis. EuroPCR 2014; Serruys, PW et al. RESOLUTE All Comers Trial, NEJM 2010. Published online June 16, 2010; Fajadet, J., et al. PLATINUM PLUS 30-day Poster, TCT 2012.

4 XIENCE showed significant benefit compared to several DES and composite BMS in multiple large scale meta-analyses and other RCTs. Palmerini, et al. The Lancet. 379:9824, 14-20 April 2012, pp. 1393-1402; Bangalore S, et al.Circ Cardiovasc Interv,Aug6,2013. doi: 10.1161/ circinterventions.113.000415.; Valgimigli, Effects of Cobalt-chromium Everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events. A patient-level meta analysis. EuroPCR 2014; Serruys, PW et al. RESOLUTE All Comers Trial, NEJM 2010. Published online June 16, 2010; Fajadet, J., et al. PLATINUM PLUS 30-day Poster, TCT 2012.