The Evoque tricuspid valve replacement system. [Image courtesy of Edwards Lifesciences]Edwards Lifesciences (NYSE:EW) today announced data highlighting the superiority of its Evoque system compared to medical therapy alone.

Evoque三尖瓣置换系统。。

The TRISCEND II evaluated the Evoque transcatheter tricuspid valve replacement (TTVR) system with optimal medical therapy (OMT) compared to OMT alone with 2:1 randomization. It found that Evoque demonstrated superiority compared to OMT alone at the one-year primary endpoint. Investigators presented the data from the full 400-patient cohort at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C..

TRISCEND II评估了具有最佳药物治疗（OMT）的Evoque经导管三尖瓣置换术（TTVR）系统，与单独使用2:1随机化的OMT相比。研究发现，与单独使用OMT相比，Evoque在一年的主要终点表现出优越性。研究人员介绍了华盛顿特区经导管心血管治疗（TCT）2024年全部400名患者队列的数据。。

Irvine, California-based Edwards won CE mark for the Evoque system about a year ago. Evoque became the first transcatheter therapy to receive an FDA nod to treat TR in February of this year.

大约一年前，总部位于加利福尼亚州欧文市的爱德华兹凭借Evoque系统赢得了CE标志。今年2月，Evoque成为第一个获得FDA批准治疗TR的经导管治疗药物。

The valve features a nitinol self-expanding frame, intra-annular skirt and tissue leaflets made from bovine pericardial tissue. Edwards intends to offer the valve in four sizes (44mm, 48mm, 52mm and 56mm), all delivered through the same low-profile transfemoral 28F system.

该瓣膜具有镍钛合金自膨胀框架，环形裙和由牛心包组织制成的组织小叶。爱德华兹打算提供四种尺寸（44mm、48mm、52mm和56mm）的瓣膜，所有瓣膜均通过相同的低剖面经股28F系统输送。

A look at the data on the Edwards Evoque system

爱德华兹极光系统的数据

Patients enrolled in TRISCEND II had at least severe tricuspid regurgitation (TR). The study saw a 95.4% implant success rate. Of those who received the valve, nearly all (95.3%) achieved almost complete TR elimination, with ≤ mild TR at one year. That compared to 2.3% of patients who received OMT alone..

参加TRISCEND II的患者至少有严重的三尖瓣关闭不全（TR）。该研究发现植入成功率为95.4%。。相比之下，仅接受OMT的患者为2.3%。。

The TR reductions came with significant improvements in symptoms, function and quality of life at one year. Edwards also reported favorable numerical outcomes in mortality and heart failure hospitalization for Evoque.

TR的减少伴随着一年后症状，功能和生活质量的显着改善。爱德华兹还报告了Evoque死亡率和心力衰竭住院率的良好数字结果。

“Edwards’ commitment to innovation is inspired by the millions of patients around the world suffering with debilitating symptoms and poor quality-of-life as a result of structural heart diseases and in desperate need of effective treatment options,” said Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies.

爱德华兹公司经导管二尖瓣和三尖瓣治疗副总裁Daveen Chopra说：“全世界数百万患者因结构性心脏病而出现衰弱症状和生活质量低下，迫切需要有效的治疗选择，这激发了爱德华兹对创新的承诺。”。

“We are building a portfolio of transcatheter repair and replacement technologies for both the mitral and tricuspid valves, and we are dedicated to supporting those therapies with world-class evidence like what is being generated through the TRISCEND II trial.”.

“我们正在为二尖瓣和三尖瓣建立一套经导管修复和置换技术组合，我们致力于用世界一流的证据支持这些疗法，如TRISCEND II试验所产生的证据。”。