/ -- Abbott (NYSE: ABT) today announced it has received CE Mark in

/ -- 雅培（纽约证券交易所代码：ABT）今天宣布已获得CE标志

Europe

欧洲

for an expanded indication for the company's Navitor™ transcatheter aortic valve implantation (TAVI) system to treat people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery. Abbott previously received CE Mark in 2021 for Navitor to treat people with symptomatic, severe aortic stenosis who are at high or extreme surgical risk.

针对公司Navitor™经导管主动脉瓣植入（TAVI）系统的一项扩展适应症，用于治疗有症状的重度主动脉瓣狭窄且开胸手术风险较低或中等的患者。Abbott公司此前在2021年获得CE认证，允许Navitor用于治疗有症状的重度主动脉瓣狭窄且手术风险较高或极高的患者。

With this new approval, Navitor is available in .

有了这项新的批准，Navitor 可以在 。

Europe

欧洲

for patients across all surgical risk categories, significantly expanding the number of people that can be treated with the device.

适用于所有手术风险类别的患者，大幅扩展了可以使用该设备治疗的人数。

The expanded indication was supported by favorable safety and effectiveness outcomes from the VANTAGE study, which was presented as a late breaker at the European Society of Cardiology (ESC) Congress 2025, held in

扩展的适应症得到了VANTAGE研究的良好安全性和有效性结果的支持，该研究作为2025年欧洲心脏病学会（ESC）大会的最新突破性报告发表。

Madrid

马德里

Aug. 29-Sept. 1, 2025

2025年8月29日-9月1日

). These data were simultaneously published in

）。这些数据同时发表在

JACC: Cardiovascular Interventions

JACC：心血管介入

'The VANTAGE study provides the scientific backbone for expanding Navitor's indication to low- and intermediate-risk patients. The data are exceptional across both populations, confirming that the Navitor valve performs precisely as designed,' said

“VANTAGE 研究为将 Navitor 的适应症扩展到低危和中危患者提供了科学依据。两个群体的数据都非常出色，证实了 Navitor 瓣膜的表现完全符合设计预期，”

Nicolas van Mieghem

尼古拉斯·范·米格姆

, M.D., medical director of the department of interventional cardiology at the Thoraxcenter,

，医学博士，Thoraxcenter介入心脏病学部主任兼医学主任，

Erasmus University

鹿特丹伊拉斯姆斯大学

Medical Centre, in

医疗中心，在

the Netherlands

荷兰

, who serves as principal investigator of the VANTAGE trial. 'Up to 50% of younger patients with aortic stenosis will also get coronary artery disease in later years, and Navitor's design preserves options and ability for lifetime disease management if future cardiac interventions are required.'

，他是VANTAGE试验的首席研究员。 “多达50%的年轻主动脉瓣狭窄患者在以后的生活中也会患上冠状动脉疾病，而Navitor的设计保留了终身疾病管理的选择权和能力，以备将来需要进行心脏干预。”

Aortic stenosis occurs when the aortic valve's opening narrows, restricting blood flow to the body. Left untreated, it can lead to heart failure and death. The Navitor TAVI device replaces the aortic valve through a minimally invasive procedure and is delivered to the heart through a small incision in the leg.

主动脉狭窄是指主动脉瓣开口变窄，限制了血液流向身体。如果不加以治疗，它可能导致心力衰竭和死亡。Navitor TAVI装置通过微创手术替换主动脉瓣，并通过腿部的小切口送达心脏。

The performance of such devices is measured by blood flow through the valve, referred to as hemodynamics..

此类装置的性能通过瓣膜的血流量来衡量，这被称为血液动力学。

Key findings from the VANTAGE trial

VANTAGE试验的主要发现

The late-breaking data presented at ESC from Abbott's VANTAGE study showed Navitor met all safety and effectiveness primary endpoints, supporting its expansion to treat people with symptomatic, severe aortic stenosis who are at low or intermediate surgical risk. Key findings include:

欧洲心脏病学会（ESC）上发布的来自雅培公司VANTAGE研究的最新数据显示，Navitor达到了所有安全性和有效性主要终点，支持其扩展用于治疗症状性重度主动脉瓣狭窄且手术风险较低或中等的患者。关键发现包括：

Excellent safety.

极佳的安全性。

In the first 262 patients with 12-month follow-up completed, there was a low rate (2.3%) of all-cause mortality or fatal stroke/stroke with disability.

在完成 12 个月随访的前 262 名患者中，全因死亡率或致死性卒中/致残性卒中的发生率较低 (2.3%)。

Proven effectiveness.

经过验证的有效性。

No patients at 30 days had moderate or greater PVL (paravalvular leak or backflow of blood around the valve) and only 13.6% had mild PVL, a rate that is considered low.

30天时，无患者出现中度或更严重的PVL（瓣周漏或瓣膜周围血液回流），仅13.6%的患者出现轻度PVL，这一比率被认为较低。

High technical success:

高技术成功率：

There was a high rate of technical success (97%) with no procedural deaths.

技术成功率较高（97%），且无手术相关死亡。

Sustained hemodynamic performance.

持续的血液动力学性能。

Excellent hemodynamic performance was seen at 12 months.

在12个月时观察到优异的血液动力学性能。

'Navitor is a strong example of how Abbott continues to evolve its structural heart portfolio to meet the growing demand for minimally invasive alternatives to open-heart surgery,' said Sandra Lesenfants, senior vice president of Abbott's structural heart business. 'Aortic stenosis is a life-threatening condition that can progress rapidly, and this expanded indication for Navitor means that patients have more options that can help reduce their symptoms and improve their lives.'.

“Navitor 是一个很好的例子，展示了 Abbott 如何持续发展其结构性心脏产品组合，以满足对微创替代开胸手术日益增长的需求，” Abbott 结构性心脏业务高级副总裁 Sandra Lesenfants 表示。“主动脉瓣狭窄是一种可能迅速恶化的危及生命的疾病，而 Navitor 的这一扩展适应症意味着患者拥有更多选择，可以帮助减轻症状并改善他们的生活质量。”

The Navitor TAVI system is currently approved in the U.S. to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

Navitor TAVI系统目前在美国被批准用于治疗有症状的重度主动脉瓣狭窄患者，这些患者进行开胸手术的风险较高或极高。

Updated transcatheter edge-to-edge repair (TEER) guidelines

更新的经导管缘对缘修复（TEER）指南

During ESC Congress 2025, ESC and the European Association for Cardio-Thoracic Surgery (EACTS) announced new guidelines for the management of valvular heart disease. Mitral valve TEER was upgraded from a treatment that

在2025年ESC大会上，欧洲心脏病学会（ESC）与欧洲心胸外科协会（EACTS）宣布了关于心脏瓣膜疾病管理的新指南。二尖瓣TEER治疗从一种

should be considered

应该被考虑

(IIa) to a

(IIa) 到 a

recommended

推荐的

treatment (Class Ia) for selected patients with severe functional (or secondary) mitral regurgitation (MR). Tricuspid valve TEER was also upgraded from a treatment that

治疗（Ia类）适用于部分严重功能性（或继发性）二尖瓣反流（MR）患者。三尖瓣TEER也从一种治疗手段升级为

may be considered

可以被认为

(IIb) to a treatment that

(IIb) 接受治疗

should be considered

应该被考虑

(Class IIa) for selected patients with severe functional tricuspid regurgitation (TR).

（IIa类）适用于部分重度功能性三尖瓣反流（TR）患者。

With these updated guidelines, there's additional support for the use of MitraClip™ and TriClip™ for MR and TR patients that is backed by evidence from multiple clinical studies, including COAPT, TRILUMINATE, TRILUMINATE Pivotal, bRIGHT, RESHAPE-HF2 and TRI.fr, that demonstrate the therapies' effectiveness..

根据这些更新的指南，有更多证据支持使用MitraClip™和TriClip™治疗二尖瓣反流（MR）和三尖瓣反流（TR）患者，这些证据来自多项临床研究，包括COAPT、TRILUMINATE、TRILUMINATE Pivotal、bRIGHT、RESHAPE-HF2和TRI.fr，证明了这些疗法的有效性。

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实地生活。我们改变生命的技术组合涵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。我们的114,000名同事为超过160个国家的人们提供服务。