NYON, Switzerland--(BUSINESS WIRE)--Edwards Lifesciences today announced it received CE Mark for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart's mitral position. The MITRIS RESILIA valve is made with innovative bovine pericardial tissue technology that reduces calcium build up on the valve.

瑞士尼昂-（BUSINESS WIRE）-爱德华兹生命科学今天宣布获得MITRIS RESILIA瓣膜的CE标志，MITRIS RESILIA瓣膜是专门为心脏二尖瓣位置设计的组织瓣膜置换术。MITRIS RESILIA valve采用创新的牛心包组织技术制造，可减少瓣膜上的钙积聚。

This technology preserves and protects the tissue, allowing the valve to potentially last longer than conventional bioprosthetic valves.*.

这项技术可以保护和保护组织，使瓣膜可能比传统的生物瓣膜持续更长时间。*。

The MITRIS RESILIA valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. The low-profile valve is based on the Edwards PERIMOUNT valve design with a nitinol wireform, which allows it to fold inward during implantation. The MITRIS RESILIA valve is visible under fluoroscopy, which facilitates potential future transcatheter interventions for patients..

MITRIS RESILIA valve具有马鞍形缝合袖口，模仿原生二尖瓣的不对称形状。低轮廓阀基于带有镍钛诺线形的Edwards PERIMOUNT阀设计，允许其在植入期间向内折叠。在透视下可以看到MITRIS RESILIA瓣膜，这有助于将来对患者进行潜在的经导管干预。。

Recent data on the RESILIA tissue from the COMMENCE aortic trial reported 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%) through seven years. Additionally, the COMMENCE mitral trial demonstrated clinically stable hemodynamics and freedom from structural valve deterioration (98,7%) at 5 years..

最近关于开始主动脉试验的RESILIA组织的数据报告了令人鼓舞的结果，结构瓣膜恶化率低（结构瓣膜恶化99.3%），临床稳定梯度和七年内无再手术（97.2%）。此外，开始的二尖瓣试验显示临床上稳定的血流动力学和5年时无结构瓣膜恶化（98.7%）。。

The RESILIA anti-calcification technology also allows devices to be stored under dry packaging conditions, facilitating ease of use.

RESILIA抗钙化技术还允许将装置储存在干燥包装条件下，便于使用。

“Mitral valve disease is prevalent and patients experience the disease in various ways. For patients who need mitral valve replacement, the advanced MITRIS RESILIA valve, designed to mimic the native valve, is based on a trusted pericardial PERIMOUNT” says Dr. Daniel Pereda Arnau, Head of Section, Cardiac Surgery Department, H.

Daniel Pereda博士说：“二尖瓣疾病普遍存在，患者以各种方式体验疾病。对于需要二尖瓣置换术的患者，设计用于模仿天然瓣膜的先进MITRIS RESILIA瓣膜基于可信的心包周围组织。”Arnau，H.心脏外科部门负责人。

Clínic de Barcelona. “As valve durability is becoming increasingly important, the integrity-preservation technology incorporated in the RESILIA tissue that will potentially allow the valve to last longer, is critical.”.

巴塞罗那Clínic。“随着阀门耐久性变得越来越重要，树脂组织中包含的完整性保存技术可能会使阀门持续更长时间，这一点至关重要。”。

Edwards is dedicated to partnering with clinicians to develop patient-centric innovations for complex surgical structural heart procedures that improve long-term care and outcomes for patients.

爱德华兹致力于与临床医生合作，为复杂的外科结构性心脏手术开发以患者为中心的创新，从而改善患者的长期护理和结果。

“Edwards Lifesciences is committed to addressing the needs of patients with structural heart disease,” says John Barry, Edwards' Senior Vice President Surgical Europe. “Our RESILIA tissue technology is designed for enhanced durability, supporting improved quality of life for patients and relieving the burden on healthcare systems.”.

爱德华兹高级副总裁欧洲外科约翰·巴里（John Barry）说：“爱德华兹生命科学公司致力于满足结构性心脏病患者的需求。“我们的RESILIA组织技术旨在增强耐久性，支持改善患者的生活质量并减轻医疗系统的负担。”。

The MITRIS RESILIA valve received FDA approval in 2022 in the United States. The introduction of the MITRIS RESILIA valve into the portfolio demonstrates Edwards’ continuous investment in innovation for the benefits and the quality of life of patients.

MITRIS RESILIA valve于2022年在美国获得FDA批准。将MITRIS RESILIA valve引入产品组合表明爱德华兹持续投资于创新，以获得患者的益处和生活质量。

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是结构性心脏病和重症监护监测患者创新的全球领导者。我们充满了对患者的热情，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合作关系来改善和改善生活。

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

欲了解更多信息，请访问Edwards.com并在LinkedIn和Twitter上关注我们。。

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, MITRIS, MITRIS RESILIA, PERIMOUNT, and RESILIA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries..

Edwards，Edwards Lifesciences，stylized E徽标，Carpentier Edwards，Carpentier Edwards PERIMOUNT，MITRIS，MITRIS RESILIA，PERIMOUNT和RESILIA是Edwards Lifesciences Corporation的商标。所有其他商标均为其各自所有者的财产。本声明代表爱德华兹生命科学公司及其子公司。。

*No clinical data are available that 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，以监测树脂组织的长期安全性和性能。

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