Abbott (NYSE: ABT) today announced that the U.S.Food and Drug Administration (FDA) has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a breakthrough innovation for people with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK). The Esprit BTK System is designed to keep arteries open and deliver a drug (Everolimus) to support vessel healing prior to completely dissolving..

雅培（纽约证券交易所：ABT）今天宣布，美国食品和药物管理局（FDA）已批准Esprit™BTK依维莫司洗脱可再吸收支架系统（Esprit BTK系统），这是一项针对膝下慢性肢体缺血（CLTI）患者的突破性创新。Esprit BTK系统旨在保持动脉开放，并在完全溶解之前提供药物（依维莫司）以支持血管愈合。。

Until today, there were no stents or drug-coated balloons approved for use below the knee in the U.S. The standard of care has been balloon angioplasty, which relies on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow.

直到今天，美国还没有批准在膝下使用支架或药物涂层球囊。标准的治疗方法是球囊血管成形术，它依靠一个小球囊通过导管输送到阻塞处，将其压在动脉壁上，打开血管并恢复血流。

However, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many instances the vessels become blocked again, requiring additional treatment..

然而，仅用球囊血管成形术治疗的阻塞短期和长期效果不佳，在许多情况下，血管再次阻塞，需要额外治疗。。

The Esprit BTK System is a first-of-its-kind dissolvable stent and is comprised of material similar to dissolving sutures. The device is implanted during a catheter-based minimally invasive procedure via a small incision in the leg. Once the blockage is open, the Esprit BTK scaffold helps heal the vessel and provides support for approximately three years until the vessel is strong enough to remain open on its own..

Esprit BTK系统是同类第一款可溶解支架，由类似于溶解缝合线的材料组成。该装置在基于导管的微创手术期间通过腿部的小切口植入。一旦堵塞物打开，Esprit BTK支架可以帮助愈合血管，并提供大约三年的支撑，直到血管足够强大，可以自行打开。。

'The FDA approval of Abbott's Esprit BTK System marks a significant milestone in our fight against peripheral artery disease below the knee and should usher in a new era of improved outcomes for people worldwide,' said Sahil A. Parikh, M.D., Columbia University Irving Medical Center, and one of the principal investigators of the LIFE-BTK trial. 'By introducing a treatment option that is superior to balloon angioplasty, Abbott is changing the landscape of CLTI therapy.'.

美国食品和药物管理局（FDA）批准雅培（Abbott）的Esprit BTK系统标志着我们对抗膝下外周动脉疾病的一个重要里程碑，应该为全世界人民带来一个改善预后的新时代。D、 ，哥伦比亚大学欧文医学中心，以及LIFE-BTK试验的主要研究人员之一。“通过引入优于球囊血管成形术的治疗方案，雅培正在改变CLTI治疗的格局。”。

The LIFE-BTK trial, which evaluated Abbott's Esprit BTK System, was presented in October 2023 as a late-breaking clinical trial at the 35th Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco and simultaneously published in the New England Journal of Medicine. The results of the trial demonstrated that the Esprit BTK System reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current standard of care..

LIFE-BTK试验评估了雅培的Esprit BTK系统，该试验于2023年10月在旧金山举行的第35届经导管心血管治疗（TCT）会议上作为一项最新的临床试验发表，并同时发表在《新英格兰医学杂志》上。试验结果表明，与目前标准的球囊血管成形术相比，Esprit BTK系统可减少疾病进展，并有助于改善医疗效果。。

PAD is highly prevalent, yet many people have never heard of the condition. More than 20 million people in the U.S. are living with this painful disease and only 10% of those people have been diagnosed.1,2 CLTI is a serious form of PAD that occurs when arteries become clogged with plaque, preventing blood flow and oxygen from reaching the lower leg and foot.

PAD非常普遍，但许多人从未听说过这种情况。美国有2000多万人患有这种痛苦的疾病，其中只有10%被诊断出。1,2 CLTI是一种严重的PAD，当动脉被斑块堵塞时会发生，阻止血流和氧气到达小腿和足部。

People living with CLTI often experience extreme pain, open wounds that don't heal and, in some cases, may have to resort to amputation. Over a five-year period, CLTI has a lower survival rate than breast, colorectal and prostate cancer combined.3.

患有CLTI的人经常会经历极度疼痛，无法愈合的开放性伤口，在某些情况下，可能不得不采取截肢措施。在五年期间，CLTI的生存率低于乳腺癌，结直肠癌和前列腺癌的总和。

'At Abbott, we've recognized the significant burden of disease and limited treatment options available for people living with the most severe form of PAD. That's why we're revolutionizing treatments with resorbable scaffold technology below the knee,' said Julie Tyler, senior vice president of Abbott's vascular business.

“在雅培，我们已经认识到疾病的巨大负担，并且对于患有最严重形式的PAD的人来说，可用的治疗选择有限。雅培血管业务高级副总裁朱莉·泰勒（JulieTyler）说，这就是为什么我们正在彻底改变膝下可吸收支架技术的治疗方法。

'Our resorbable program is focused on meeting unmet needs in the peripheral anatomy to help people live better and fuller lives.'.

“我们的可再吸收计划专注于满足周围解剖结构中未满足的需求，以帮助人们过上更好、更充实的生活。”。

As part of Abbott's continued commitment to helping all people live healthier lives, PAD and CLTI education information can be found at www.PAD-info.com. Physicians can find more information at www.CLEAR.abbott.

作为雅培继续致力于帮助所有人过上更健康的生活的一部分，PAD和CLTI的教育信息可以在www.PAD-info.com上找到。医生可以在www.CLEAR.Abbott上找到更多信息。

About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries..

AbbottAbbott是一家全球医疗保健领导者，致力于帮助人们在生命的各个阶段都生活得更加充实。我们的生命改变技术组合涵盖了医疗保健领域，拥有诊断、医疗器械、营养品和品牌仿制药领域的领先业务和产品。我们的114000名同事为160多个国家的人民服务。