IRVINE, Calif., Oct. 19, 2023 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW) today announced the company's EVOQUE tricuspid valve replacement system received CE Mark for the transcatheter treatment of eligible patients with tricuspid regurgitation (TR). The EVOQUE system is the world's first transcatheter valve replacement therapy to receive regulatory approval to treat TR. .

加利福尼亚州欧文市，2023年10月19日/PRNewswire/-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三尖瓣置换系统获得CE标志，用于经导管治疗符合条件的三尖瓣反流患者（TR）。EVOQUE系统是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。

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Edwards Lifesciences EVOQUE transcatheter tricuspid valve replacement system.

Edwards Lifesciences EVOQUE经导管三尖瓣置换系统。

'Innovating for unmet patient needs is at the center of everything we do at Edwards, which makes us especially proud to have received CE Mark for this first-of-its-kind transcatheter tricuspid valve replacement therapy,' said Daveen Chopra, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies.

爱德华兹公司副总裁Daveen Chopra说：“为未满足的患者需求创新是我们在爱德华兹所做的一切的核心，这使我们特别自豪地为这种首次经导管三尖瓣置换术获得CE标志，经导管二尖瓣和三尖瓣治疗。

'With the EVOQUE system's approval, in addition to our current PASCAL tricuspid system, we are now able to provide a broader array of much-needed treatment options for appropriate tricuspid disease patients in Europe.'.

“随着EVOQUE系统的批准，除了我们目前的PASCAL三尖瓣系统，我们现在能够为欧洲合适的三尖瓣疾病患者提供更广泛的急需治疗方案。”。

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

EVOQUE系统由镍钛合金自膨胀框架，环形内密封裙和由与公司市场领先的心脏瓣膜相同的牛心包组织制成的组织小叶组成。EVOQUE阀门将有三种尺寸可供选择，全部通过低调的经股动脉28F系统提供。。

'The EVOQUE system is able to fully replace the tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of anatomies,' said Prof. Philipp Lurz, Director of Cardiology, University of Mainz, Germany and European Principal Investigator for the TRISCEND II study. 'The significant improvements in patients' quality-of-life are remarkable, now offering a therapy to many patients who previously had no treatment options.'One-year results on patients treated in the single-arm, prospective, global, multi-center TRISCEND study of the EVOQUE system were presented at PCR London Valves 2022 and demonstrated favorable safety and effectiveness outcomes and significant quality-of-life improvements.

德国美因茨大学心脏病学系主任，欧洲TRISCEND II研究首席研究员Philipp Lurz教授说：“EVOQUE系统能够完全替代三尖瓣，实际上消除了各种解剖结构中的三尖瓣反流。”患者生活质量的显着改善是显着的，现在为许多以前没有治疗选择的患者提供治疗在PCR London Valves 2022上介绍了在EVOQUE系统的单臂，前瞻性，全球，多中心三中心研究中治疗的患者的一年结果，并证明了有利的安全性和有效性结果以及显着的生活质量改善。

Key findings included high survival (90.1%) and high freedom from heart failure hospitalization (88.4%); significant and sustained TR reduction to mild or trace TR (97.6%); and significantly improved functional and quality-of-life outcomes (93% of patients in NYHA Class I or II compared to 26% at baseline and a 26-point increase in KCCQ score over baseline).The company will present results from the TRISCEND II pivotal trial, studying the EVOQUE system, during a late-breaking clinical trial session on Oct.

主要发现包括高生存率（90.1%）和心力衰竭住院率高（88.4%）；显着和持续的TR降低至轻度或微量TR（97.6%）；并显着改善功能和生活质量结果（NYHA I级或II级患者中93%的患者与基线时的26%相比，KCCQ评分比基线增加26分）。该公司将提供TRISCEND II pivotal在10月的一次突破性临床试验期间，研究EVOQUE系统的试验。

26 in San Francisco at the 35th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.Patients with tricuspid valve disease suffer greatly with symptoms ranging from debilitating to life-threatening with few effective options for relief.

26在旧金山举行的第35届经导管心血管治疗（TCT）心血管研究基金会年度科学研讨会上。三尖瓣疾病患者的症状从衰弱到危及生命，几乎没有有效的缓解方案。

Other transcatheter therapies in Edwards' tricuspid portfolio with CE Mark approval include the PASCAL Precision transcatheter repair system and the Cardioband annular reduction system. The company does not yet have any transcatheter therapies approved for treatment of.

爱德华兹三尖瓣CE标志批准的其他经导管治疗包括PASCAL精密经导管修复系统和Cardioband环形复位系统。该公司尚未批准任何经导管疗法用于治疗。