/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved the company's Tendyne™ transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease. This life-changing therapy is available for patients whose mitral valves are not functioning properly due to severe mitral annular calcification (MAC), a buildup of calcium within the ring-like structure (known as an annulus) that supports the mitral valve..

/ -- 雅培公司（纽约证券交易所代码：ABT）今天宣布，美国食品药品监督管理局 (FDA) 已批准该公司研发的 Tendyne™ 经导管二尖瓣置换 (TMVR) 系统，用于治疗二尖瓣疾病患者。这一改变生命的疗法适用于因严重二尖瓣环钙化 (MAC) 导致二尖瓣无法正常工作的患者。MAC 是指在支撑二尖瓣的环状结构（称为瓣环）内钙的堆积。

The complex nature of mitral valve disease and patients' specific needs and health conditions can pose challenges for surgical correction. For patients with severe MAC who are at high risk for open-heart surgery and whose mitral valve cannot be successfully repaired with the Abbott MitraClip™ device, Tendyne offers an alternative minimally invasive way to replace the valve that's leaky (mitral regurgitation) or narrowed (stenosis)..

二尖瓣疾病复杂的性质以及患者特定的需求和健康状况可能会给手术矫正带来挑战。对于严重MAC且开胸手术风险较高、 Abbott MitraClip™ 设备无法成功修复二尖瓣的患者，Tendyne 提供了一种替代性的微创方法来替换泄漏（二尖瓣反流）或狭窄（狭窄症）的瓣膜。

'Mitral annular calcification stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupt the heart's ability to pump blood effectively. These conditions can have a significant impact on a patient's quality of life, causing symptoms such as chest pains, shortness of breath and dizziness,' said .

“二尖瓣环钙化使二尖瓣的结构变得僵硬，可能导致二尖瓣反流或狭窄，从而影响心脏有效泵血的能力。这些情况可能对患者的生活质量产生重大影响，引发胸痛、呼吸急促和头晕等症状，”他表示。

Paul Sorajja

保罗·索拉贾

, M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital. 'Unfortunately, patients with MAC can be very difficult to operate on and many are considered too high risk for open-heart surgery due to multiple co-morbidities or other factors.

医学博士，明尼阿波利斯心脏研究所基金会阀门科学中心的罗杰·L·亨德里克和林恩·C·亨德里克家族主席，同时也是Abbott Northwestern医院明尼阿波利斯心脏研究所阀门与结构性心脏病中心主任。 “不幸的是，MAC患者往往难以进行手术操作，且由于多种并发症或其他因素，许多患者被认为进行开胸心脏手术风险过高。”

Tendyne bridges a critical treatment gap for these patients and can help reduce the symptoms that can interfere with their lives.'.

Tendyne 弥补了这些患者的关键治疗缺口，并有助于减轻可能干扰他们生活的症状。

The innovative and unique design of the Abbott Tendyne system and the valve's availability in multiple sizes allows it to adapt to a range of patient anatomies. The self-expanding valve is delivered through a small incision in the chest and then advanced into the heart to replace the mitral valve. The valve is fully repositionable and retrievable during implantation, allowing for the best possible outcome for people requiring a valve replacement..

雅培Tendyne系统的创新独特设计以及该瓣膜有多种尺寸可供选择，使其能够适应不同患者的解剖结构。这种自膨胀瓣膜通过胸部的小切口送入，然后被引导至心脏以替换二尖瓣。在植入过程中，该瓣膜可以完全重新定位和回收，从而为需要瓣膜置换的患者带来最佳效果。

'Tendyne is a much-needed addition to our comprehensive U.S. structural heart portfolio that offers less invasive treatment options for a range of heart diseases,' said Sandra Lesenfants, senior vice president of Abbott's structural heart business. 'This approval builds on our more than two decades of mitral valve leadership that includes developing first-of-their-kind devices that truly change – and save – people's lives.'.

“Tendyne 是我们全面的美国结构性心脏产品组合中非常必要的补充，为多种心脏疾病提供了微创治疗选择，”雅培结构性心脏业务高级副总裁桑德拉·莱森方特表示。“此次批准建立在我们二十多年的二尖瓣领域领导地位之上，其中包括开发出真正改变和拯救生命、前所未有的设备。”

About Abbott

关于雅培

Abbott 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..

Abbott是一家全球医疗保健领域的领导者，致力于帮助人们在生命的各个阶段更充分地生活。我们变革性的技术组合覆盖了整个医疗保健领域，在诊断、医疗器械、营养品和品牌仿制药方面拥有领先的业务和产品。我们11.4万名员工为超过160个国家的人们提供服务。