NYON, Switzerland--(BUSINESS WIRE)--Edwards Lifesciences today announced the European launch of the SAPIEN 3 Ultra RESILIA valve, the only transcatheter aortic heart valve to incorporate the company’s breakthrough RESILIA tissue technology, designed to extend the valve’s durability.*

瑞士尼昂--（商业新闻短讯）--爱德华兹生命科学公司今天宣布在欧洲推出SAPIEN 3 Ultra RESILIA瓣膜，这是唯一一种采用该公司突破性RESILIA组织技术的经导管主动脉瓣，旨在延长瓣膜的耐久性*

Edwards’ SAPIEN 3 Ultra RESILIA valve recently received CE Mark† for use in patients with heart valve disease due to native calcific aortic stenosis at all levels of surgical risk or due to the failure of either a transcatheter or a surgical bioprosthetic valve who are judged to be at high or greater risk for open surgical therapy..

爱德华兹（Edwards）的SAPIEN 3 Ultra RESILIA瓣膜最近获得CE Mark†，用于因各种手术风险的天然钙化性主动脉瓣狭窄或因经导管或手术生物瓣膜失败而导致的心脏瓣膜病患者，这些患者被认为是开放手术治疗的高风险或更高风险。。

“Today’s patients are living longer, more active lives, with high expectations for their health and quality of life, so lifetime management of heart valve disease, starting with the first valve, is increasingly important,” said Flavio Ribichini, professor of cardiovascular medicine at the University of Verona.

维罗纳大学心血管医学教授弗拉维奥·里比奇尼（FlavioRibichini）说：“今天的患者寿命更长，更活跃，对他们的健康和生活质量有很高的期望，因此从第一个瓣膜开始的心脏瓣膜病的终身管理越来越重要。”。

“SAPIEN 3 Ultra RESILIA gives these patients a promising option, as RESILIA tissue’s calcium-blocking technology addresses structural valve deterioration, one of the primary causes of reintervention following heart valve replacement.”.

“SAPIEN 3 Ultra RESILIA为这些患者提供了一个有希望的选择，因为RESILIA组织的钙阻断技术解决了结构性瓣膜恶化，这是心脏瓣膜置换术后再次介入的主要原因之一。”。

Edwards RESILIA is a bovine pericardial tissue treated with advanced anti-calcification technology that provides the potential to extend the durability of the SAPIEN 3 Ultra RESILIA valve.*

Edwards RESILIA是一种牛心包组织，采用先进的抗钙化技术进行治疗，有可能延长SAPIEN 3 Ultra RESILIA瓣膜的耐久性*

RESILIA tissue is already used in the world’s leading surgical aortic valve, the Edwards INSPIRIS RESILIA valve. Recent data on the RESILIA tissue from the 7-year COMMENCE Study showed encouraging results with low rates of structural valve deterioration (99.3% freedom from structural valve deterioration), clinically stable gradients and freedom from reoperation (97.2%).‡.

RESILIA组织已经用于世界领先的外科主动脉瓣Edwards INSPIRIS RESILIA瓣膜。最近来自7年BECTURE研究的RESILIA组织数据显示，令人鼓舞的结果显示，结构性瓣膜恶化率低（99.3%无结构性瓣膜恶化），临床稳定梯度和无再次手术（97.2%）。

“RESILIA tissue is the result of nearly 20 years of research and development and is a prime example of Edwards’ continued focus on delivering technology that puts patients first​,” said Gregory Servotte, senior vice president of transcatheter heart valves EU at Edwards Lifesciences. “Latest data emphasize the value of RESILIA tissue in the lifetime management of valve disease.‡§ The SAPIEN 3 Ultra RESILIA valve utilizes this technology with the aim of improving quality of life, offering sustainable long-term patient outcomes and making future treatment options possible.”.

“RESILIA组织是近20年研究和开发的结果，是爱德华兹继续专注于提供以患者为先的技术的一个主要例子​,” 爱德华兹生命科学公司经导管心脏瓣膜欧盟高级副总裁格雷戈里·塞沃特说。“最新数据强调了RESILIA组织在瓣膜疾病终身管理中的价值。‡§SAPIEN 3 Ultra RESILIA瓣膜利用这项技术，旨在提高生活质量，提供可持续的长期患者结果，并使未来的治疗选择成为可能。”。

In addition to its anti-calcification properties, RESILIA tissue allows the valve to be stored under dry packaging conditions, facilitating ease of use. Today, the SAPIEN 3 Ultra RESILIA valve is the only transcatheter heart valve on the market with dry tissue storage.

除了抗钙化特性外，RESILIA组织还可以将瓣膜保存在干燥的包装条件下，方便使用。今天，SAPIEN 3 Ultra RESILIA瓣膜是市场上唯一具有干组织储存的经导管心脏瓣膜。

At Cardiovascular Research Technologies (CRT) 2024, Dr. Curtiss Stinis presented compelling results from a large, real-world study (10,314 patients), based on US TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform. A study of the SAPIEN 3 Ultra RESILIA valve found lower rates of paravalvular leak (PVL) at 30 days, lower echo-derived gradients and larger effective orifice areas across all valve sizes when compared to the SAPIEN 3 and SAPIEN 3 Ultra valves..

在2024年心血管研究技术（CRT）上，Curtiss Stinis博士根据美国TVT登记数据，从一项大规模的现实世界研究（10314名患者）中得出了令人信服的结果，该数据证明了爱德华兹·萨皮恩瓣膜平台治疗患者的持续良好结果。对SAPIEN 3 Ultra RESILIA瓣膜的一项研究发现，与SAPIEN 3和SAPIEN 3 Ultra瓣膜相比，30天时瓣膜旁漏（PVL）的发生率较低，回声梯度较低，所有瓣膜尺寸的有效孔口面积较大。。

Notes to Editors

编辑注释

* De La Fuente AB, et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.

*先进的完整性保存技术可减少生物假体钙化，同时保持性能和安全性。J心脏瓣膜疾病。2015年1月；24（1）：101-9。

† The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valve system is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator)..

†Edwards SAPIEN 3，SAPIEN 3 Ultra和SAPIEN 3 Ultra RESILIA经导管心脏瓣膜系统适用于因天然钙化性主动脉瓣狭窄而患有心脏病的患者，无论是否存在心脏直视手术的手术风险。Edwards SAPIEN 3、SAPIEN 3 Ultra和SAPIEN 3 Ultra RESILIA经导管心脏瓣膜系统适用于因主动脉经导管生物瓣膜或外科主动脉瓣或二尖瓣生物瓣膜衰竭（狭窄、不足或合并）而出现症状性心脏病的患者，这些患者由包括心脏外科医生在内的心脏团队判断为开放手术治疗的高风险或更高风险（即根据胸外科医师协会（STS）风险评分和STS风险计算器未测量的其他临床合并症，预测30天手术死亡率≥8%）。。

‡ Beaver T, Bavaria J, Griffith B, et al. Seven-Year Outcomes Following Aortic Valve Replacement with a Novel Tissue Bioprosthesis. J Thorac Cardiovasc Surg. 2023 Sep 29:S0022-5223(23)00873-5.

‡Beaver T，Bavaria J，Griffith B等。用新型组织生物假体置换主动脉瓣后的七年结果。《胸心血管外科杂志》，2023年9月29日：S0022-5223（23）00873-5。

§ Stinis CT, Abbas AE, Teirstein P, et al. Real-World Outcomes for the Fifth-Generation Balloon Expandable Transcatheter Heart Valve in the United States. JACC Cardiovasc Interv. 2024 Apr 22;17(8):1032-1044.

§Stinis CT，Abbas AE，Teirstein P等人。美国第五代球囊扩张经导管心脏瓣膜的现实世界结果。JACC心血管介入治疗。2024年4月22日；17（8）：1032-1044。

No clinical data are available to evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.

没有临床数据可用于评估RESILIA组织对患者的长期影响。正在收集长达10年随访的其他临床数据，以监测RESILIA组织的长期安全性和性能。

About Edwards Lifesciences

关于爱德华兹生命科学

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape.

爱德华兹生命科学公司（Edwards Lifesciences）是结构性心脏病和重症监护领域以患者为中心的创新的全球领导者。我们以对患者的热情为动力，致力于通过与全球医疗保健领域的临床医生和利益相关者建立伙伴关系来改善和改善生活。

For more information, visit Edwards.com and follow us on LinkedIn and X..

有关更多信息，请访问Edwards.com，并在LinkedIn和X上关注我们。。

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, Edwards SAPIEN 3 Ultra RESILIA, Edwards INSPIRIS RESILIA, INSPIRIS RESILIA, INSPIRIS, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA are trademarks of Edwards Lifesciences Corporation.

Edwards、Edwards Lifesciences、stylized E徽标、Edwards SAPIEN、Edwards SAPIEN 3、Edwards SAPIEN 3 Ultra、Edwards SAPIEN 3 Ultra RESILIA、Edwards INSPIRIS RESILIA、INSPIRIS RESILIA、INSPIRIS RESILIA、SAPIEN、SAPIEN 3、SAPIEN 3 Ultra和SAPIEN 3 Ultra RESILIA是Edwards Lifesciences Corporation的商标。

All other trademarks are the property of their respective owners..

所有其他商标均为其各自所有者的财产。。