IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s EVOQUE tricuspid valve replacement system is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation (TR). The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team..

爱德华兹生命科学公司（纽约证券交易所：EW）今天宣布，该公司的EVOQUE三尖瓣置换系统是第一个获得美国食品和药物管理局（FDA）批准用于治疗三尖瓣关闭不全（TR）的经导管治疗方法。EVOQUE系统适用于改善症状严重TR患者的健康状况，尽管有最佳药物治疗（OMT），心脏团队认为三尖瓣置换术是合适的。。

“Edwards has a long history of leading innovation and pioneering new therapies to address the unmet needs of patients with structural heart disease,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “We are grateful for the strong collaboration with clinicians all over the world who contributed to the EVOQUE system now being available through FDA’s Breakthrough Pathway to provide a treatment option to the many patients in the US suffering with tricuspid valve disease.”.

爱德华兹公司经导管二尖瓣和三尖瓣治疗副总裁Daveen Chopra说：“爱德华兹在领导创新和开创新疗法以解决结构性心脏病患者未满足的需求方面有着悠久的历史。”。“我们感谢与世界各地的临床医生的密切合作，他们通过FDA的突破性途径为EVOQUE系统做出了贡献，为美国许多患有三尖瓣疾病的患者提供了治疗选择。”。

The EVOQUE system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s proven bovine pericardial tissue. The EVOQUE valve will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.

EVOQUE系统由镍钛合金自膨胀框架、环形密封裙和由该公司经验证的牛心包组织制成的组织小叶组成。EVOQUE瓣膜将有三种尺寸，均通过相同的低剖面经股28F系统输送。

“Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” said Susheel Kodali, MD, director, Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and TRISCEND II Study Principal Investigator.

哥伦比亚大学欧文医学中心/纽约长老会医院结构性心脏和瓣膜中心主任兼TRISCEND II研究首席研究员Susheel Kodali博士说：“患有三尖瓣关闭不全的患者会出现危及生命的症状，直到今天，还没有经批准的经导管治疗选择。”。

“The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients. We see significant improvements in patients’ symptoms and quality-of-life, including not feeling short of breath and being able to care for themselves, which ranked highest on a patient preference survey conducted at baseline with TRISCEND II pivotal trial patients.”.

“EVOQUE系统能够替代天然三尖瓣，实际上消除了广泛患者的三尖瓣关闭不全。我们看到患者的症状和生活质量有了显着改善，包括不感到呼吸急促和能够照顾自己，这在TRISCEND II pivotal tri基线进行的患者偏好调查中排名最高所有患者。”。

Successful six-month results from the randomized controlled pivotal trial, TRISCEND II, were presented at TCT 2023 and reported favorable safety and effectiveness outcomes, demonstrating superiority to OMT alone and meeting all primary endpoints. Key findings in the trial included significant reduction or elimination of tricuspid regurgitation and significant and sustained quality of life improvement, while demonstrating a favorable balance between risk and benefit..

随机对照关键试验TRISCEND II的成功六个月结果在TCT 2023上发表，并报告了良好的安全性和有效性结果，证明优于单独的OMT并满足所有主要终点。该试验的主要发现包括显着减少或消除三尖瓣关闭不全，显着和持续的生活质量改善，同时显示出风险和收益之间的良好平衡。。

In addition to the six-month cohort, 318 of the total 392 randomized patients completed a 1-year visit. The results showed favorable trends in the device group compared to the control group in the primary composite endpoints, including all-cause mortality, tricuspid intervention, heart failure hospitalization, KCCQ, NYHA and 6MWD.

除了为期六个月的队列研究外，392名随机患者中有318名完成了1年的随访。结果显示，与对照组相比，装置组在主要复合终点（包括全因死亡率，三尖瓣介入治疗，心力衰竭住院治疗，KCCQ，NYHA和6MWD）方面有良好的趋势。

Edwards expects to present the full cohort of 392 TRISCEND II pivotal trial patients at TCT 2024..

爱德华兹预计将在2024年TCT上展示392名TRISCEND II关键试验患者的完整队列。。

The EVOQUE system received CE Mark approval in October 2023, making it the world’s first transcatheter valve replacement therapy to receive regulatory approval to treat TR.

EVOQUE系统于2023年10月获得CE标志批准，成为世界上第一个获得监管部门批准治疗TR的经导管瓣膜置换疗法。

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 Facebook, Instagram, LinkedIn, X and YouTube..

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

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra and Dr.

本新闻稿包括经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。这些前瞻性声明包括但不限于Chopra先生和Dr。

Kodali, and statements regarding expected product benefits, patient outcomes, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict.

Kodali，以及关于预期产品益处，患者结果，目标和期望的陈述以及其他非历史事实的陈述。前瞻性陈述基于公司管理层做出的估计和假设，虽然它们本身不确定且难以预测，但被认为是合理的。

Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements..

我们的前瞻性声明仅在发布之日起生效，我们没有义务更新任何前瞻性声明以反映声明日期后的事件或情况。提醒投资者不要过度依赖此类前瞻性声明。。

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2022, and its Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2023.

前瞻性陈述涉及风险和不确定性，这些风险和不确定性可能会导致结果与前瞻性陈述所明示或暗示的结果产生重大差异，这些差异基于公司向证券交易委员会提交的文件中详述的许多因素，包括截至2022年12月31日的10-K表格年度报告，以及截至2023年3月31日、6月30日和9月30日的季度报表10-Q。

These filings, along with important safety information about our products, may be found at Edwards.com..

这些文件以及有关我们产品的重要安全信息可以在爱德华兹网站上找到。。

Edwards, Edwards Lifesciences, the stylized E logo, Edwards EVOQUE, EVOQUE, and TRISCEND are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Edwards、Edwards Lifesciences、stylized E徽标、Edwards EVOQUE、EVOQUE和TRISCEND是Edwards Lifesciences Corporation的商标。所有其他商标均为其各自所有者的财产。