Edwards Lifesciences currently holds over 60% of the US TAVR market. Image credit: Steve Cukrov via Shutterstock.

爱德华生命科学目前占据美国经导管主动脉瓣置换术市场60%以上的份额。图片来源：Steve Cukrov 通过 Shutterstock。

The US Food and Drug Administration (FDA) has approved Edwards Lifesciences’ SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for the treatment of patients with asymptomatic severe aortic stenosis (AS), expanding its use to a broader population.

美国食品药品监督管理局（FDA）已批准爱德华生命科学公司的SAPIEN 3经导管主动脉瓣置换术（TAVR）平台用于治疗无症状的重度主动脉瓣狭窄（AS）患者，将其使用范围扩大到更广泛的人群。

Marking a first approval for a TAVR system’s use in asymptomatic AS patients, the agency’s decision was based on data from Edwards’ EARLY TAVR trial.

基于爱德华兹公司EARLY TAVR试验的数据，该机构的决定标志着首次批准将TAVR系统用于无症状AS患者。

Published last year, the trial results demonstrated that asymptomatic severe AS patients randomised to Edwards’ TAVR experienced

去年发布的试验结果表明，随机分配到 Edwards 的 TAVR 的无症状重度 AS 患者经历了

superior outcomes versus guideline-recommended clinical surveillance

优于指南推荐的临床监测结果

(watchful waiting).

（观察等待）。

With a median follow-up of 3.8 years, 26.8% of the 455 patients in the trial’s TAVR arm experienced death, stroke or unplanned cardiovascular hospitalisation versus 45.3% of the 446 patients in the clinical surveillance arm. The randomised control trial was the first to study the best approach to treating asymptomatic severe AS patients and evaluate the benefits of early intervention with TAVR..

在中位随访3.8年时，试验的TAVR组455名患者中有26.8%经历了死亡、中风或计划外心血管住院，而临床监测组446名患者中有45.3%发生了上述情况。这项随机对照试验是首个研究治疗无症状重度AS患者最佳方法，并评估早期采用TAVR干预益处的试验。

Dr Philippe Genereux, director of the structural heart programme at Gagnon Cardiovascular Institute at Morristown Medical Center, asserted that there is an “urgent need” to change the TAVR treatment guideline’s ‘watchful waiting’ until symptoms develop approach to the care pathway for aortic stenosis patients..

菲利普·热内鲁克斯博士，莫里斯敦医疗中心加格农心血管研究所心脏结构项目主任，断言对于主动脉狭窄患者的治疗路径，TAVR治疗指南中“观察等待直至症状出现”的方法有“迫切改变的需求”。

According to

根据

data

数据

first shared by Edwards at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo 2025 in March, one in ten patients experiencing symptoms of severe AS may die within five weeks if left untreated.

首次由 Edwards 在 2025 年 3 月的美国心脏病学会（ACC）年度科学会议及博览会上分享，十分之一的严重主动脉瓣狭窄（AS）症状患者如果未经治疗，可能在五周内死亡。

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Genereux said: “As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system.”

热内鲁说：“正如我们在EARLY TAVR试验中看到的那样，最初被指定为无症状的患者会以突然且不可预测的方式出现症状，这突显了心脏团队早期评估的重要性，以改善患者预后并使医疗保健系统受益。”

Larry Wood, Edwards’ corporate vice president and TAVR and surgical group president, called the approval a “powerful opportunity” to streamline patient care and improve the efficiency of the healthcare system.

爱德华公司的副总裁兼TAVR和外科部门总裁拉里·伍德称，这一批准是简化患者护理并提高医疗系统效率的“强有力的机会”。

According to GlobalData analysis, the global TAVR market is forecast to reach a valuation of around $13.7bn by 2033, up from $6.16bn in 2023.

根据 GlobalData 的分析，全球 TAVR 市场预计到 2033 年将达到约 137 亿美元，高于 2023 年的 61.6 亿美元。

GlobalData’s US Healthcare Facility Invoicing Database indicates that Edwards Lifesciences is currently the TAVR market leader, holding more than 60% of the US TAVR market. But change may be afoot.

GlobalData的美国医疗设施发票数据库显示，爱德华生命科学公司目前是TAVR市场的领导者，占据美国TAVR市场60%以上的份额。但变化可能正在酝酿中。

Medtronic recently released two-year results from a clinical trial comparing its Evolut system to Edwards’ SAPIEN, with the data showing that the Evolut system led to significantly less bioprosthetic valve dysfunction, five times less prosthetic valve thrombosis, and nine times less haemodynamic structural valve dysfunction than the SAPIEN system..

美敦力最近发布了将其Evolut系统与爱德华的SAPIEN系统进行比较的临床试验两年结果，数据显示，Evolut系统导致的生物瓣膜功能障碍显著减少，人工瓣膜血栓形成减少五倍，血液动力学结构性瓣膜功能障碍减少九倍。

According to GlobalData analysis, the

根据 GlobalData 分析，

Evolut system

进化系统

could become the preferred option among healthcare professionals for patients with symptomatic severe aortic stenosis and small aortic annulus categories, as evaluated in the trial.

在试验中评估后，可能成为治疗症状性重度主动脉瓣狭窄且主动脉瓣环较小患者的首选方案。

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