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首次全女性TAVI试验显示,接受Edwards瓣膜的女性效果良好

First All-Female TAVI Trial Shows Excellent Outcomes for Women Receiving Edwards Valves

businesswire 等信源发布 2024-08-31 22:35

可切换为仅中文


LONDON--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced the results from the RHEIA Trial, a first-of-its-kind trial focused exclusively on outcomes for women receiving transcatheter aortic valve implantation (TAVI). Presenting one-year results during a Hot Line session at the ESC Congress 2024, investigators reported superior outcomes for women receiving the Edwards SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valves as compared to those receiving surgical aortic valve replacement (SAVR)..

伦敦--(商业新闻短讯)--爱德华兹生命科学公司(纽约证券交易所:EW)今天宣布了RHEIA试验的结果,这是首次专门针对接受经导管主动脉瓣植入术(TAVI)的女性的试验结果。研究人员在2024年ESC大会的热线会议上介绍了一年的结果,他们报告说,与接受外科主动脉瓣置换术(SAVR)的女性相比,接受Edwards SAPIEN 3 Ultra或SAPIEN 3 Ultra RESILIA瓣膜的女性取得了更好的结果。。

'Women are an underrepresented group in the diagnosis and treatment of severe aortic stenosis and this landmark study provides important insights into their treatment options,” said Hélène Eltchaninoff, M.D., head of the department of cardiology at the University Hospital of Rouen. “The transcatheter and surgical arms achieved remarkable results and the performance of the transcatheter valves adds to a growing body of evidence on the treatment options available to women.”.

。“经导管和手术臂取得了显着的成果,经导管瓣膜的性能增加了越来越多关于女性可用治疗选择的证据。”。

In the evaluation of composite 1-year endpoints, TAVI was found to be superior to SAVR with 8.9% of TAVI patients experiencing death, stroke or rehospitalization versus 15.6% in the SAVR cohort. The independently run RHEIA Trial included 440 female patients with an average age of 73, randomized to TAVI or SAVR to investigate outcomes of Edwards TAVI compared to surgery in an all-comers female patient population suffering from severe symptomatic aortic stenosis.

在综合1年终点的评估中,发现TAVI优于SAVR,8.9%的TAVI患者经历死亡,中风或再住院,而SAVR队列中为15.6%。独立运行的RHEIA试验包括440名平均年龄为73岁的女性患者,随机分为TAVI或SAVR,以调查爱德华兹TAVI与患有严重症状性主动脉瓣狭窄的全方位女性患者人群的手术结果。

The RHEIA Trial, which was investigator initiated and supported by Edwards, was conducted across 48 sites in 12 European countries..

RHEIA试验是由爱德华兹(Edwards)发起和支持的研究者发起的,在12个欧洲国家的48个地点进行。。

“We are proud of this high-quality clinical research to inform patients’ decisions about the treatment of their heart valve failure,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “The outstanding success of the TAVI group points to the importance of valve selection for women undergoing aortic valve replacement – especially those women with small annuli – to preserve their options for a future valve-in-valve procedure, ensuring the lifetime management of their disease.”.

爱德华兹公司副总裁兼经导管主动脉瓣置换术和外科结构性心脏集团总裁拉里·伍德(LarryWood)表示:“我们为这项高质量的临床研究感到骄傲,该研究为患者决定如何治疗心脏瓣膜衰竭提供了信息。”。“TAVI小组取得的杰出成功表明,对于接受主动脉瓣置换术的女性,尤其是那些环空较小的女性,选择瓣膜的重要性,以保留他们对未来瓣膜置换术的选择,确保其疾病的终身管理。”。

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 Facebook, Instagram, LinkedIn and YouTube..

有关更多信息,请访问Edwards.com,并在Facebook、Instagram、LinkedIn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. We intend the forward-looking statements contained in this Proxy Statement to be covered by the safe harbor provisions of such Acts.

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。我们打算将本委托书中包含的前瞻性声明纳入此类法案的安全港条款。

These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr.

这些前瞻性陈述有时可以通过使用前瞻性词语来识别,例如“可能”、“可能”、“相信”、“将”、“期望”、“项目”、“估计”、“应该”、“预期”、“计划”、“目标”、“继续”、“寻求”、“打算”、“乐观”、“渴望”、“自信”和这些词语的其他形式,包括但不限于先生的陈述。

Wood and statements regarding expected product benefits, patient outcomes, post-treatment reduction of invasive procedures, 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.

Wood和关于预期产品益处,患者结局,治疗后减少侵入性手术,目标和期望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,被认为是合理的,尽管它们本质上是不确定的,难以预测。

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

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导致结果与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的前瞻性陈述所明示或暗示的结果产生重大差异。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 SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, RESILIA, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Edwards、Edwards Lifesciences、stylized E徽标、Edwards SAPIEN、Edwards SAPIEN 3、Edwards SAPIEN 3 Ultra、RESILIA、SAPIEN、SAPIEN 3和SAPIEN 3 Ultra是Edwards Lifesciences Corporation的商标。所有其他商标均为其各自所有者的财产。