Meril Life Sciences' LANDMARK trial, highlighting the safety and effectiveness of the Myval Transcatheter Heart Valve Series, stands out as a key late-breaking trial at EuroPCR 2024. The trial involving 768 patients across 31 sites underscores Meril's dedication to research and patient well-being.

Meril Life Sciences的里程碑式试验突出了Myval经导管心脏瓣膜系列的安全性和有效性，是EuroPCR 2024的一项关键的晚期突破性试验。该试验涉及31个地点的768名患者，突显了梅里尔致力于研究和患者福祉。

VAPI, India, May 15, 2024 /PRNewswire/ -- Exciting news from Meril Life Sciences! The LANDMARK trial's 30 days primary outcomes were presented on 15th May at EuroPCR 2024, Paris, France. LANDMARK was recognized by EuroPCR as one of the top three late breaking trials poised to transform current practices in the field of Interventional Cardiology..

瓦皮，印度，2024年5月15日/PRNewswire/--来自梅里尔生命科学的令人兴奋的消息！这项具有里程碑意义的试验为期30天的主要结果于5月15日在法国巴黎的EuroPCR 2024上公布。LANDMARK被EuroPCR认定为有望改变介入心脏病学领域当前实践的前三大突破性试验之一。。

The LANDMARK study showed that the performance of Myval THV series in terms of safety and effectiveness was non-inferior to the contemporary THV series (24.7% vs. 27.0%, occurrence of primary composite endpoint which is composite of deaths, stroke, major bleeding, acute kidney injury, major vascular complications, moderate or severe valve regurgitation, and the need for new permanent pacemaker implantation as per the third Valve Academic Research Consortium consensus) with no difference in the itemized components of the primary composite endpoints.

这项具有里程碑意义的研究表明，Myval THV系列在安全性和有效性方面的表现不逊于当代THV系列（24.7%比27.0%，主要复合终点的发生率是死亡，中风，大出血，急性肾损伤，主要血管并发症，中度或重度瓣膜返流，以及根据第三瓣膜学术研究联盟共识需要植入新的永久起搏器），主要复合终点的分项成分没有差异。

The other secondary endpoints including technical success at exit from procedure room, device success at 30 days and early safety at 30 days were comparable in both the groups..

其他次要终点包括退出手术室的技术成功，30天的设备成功和30天的早期安全性在两组中都是可比的。。

Professor Serruys, Chairman & study director of the LANDMARK trial, said 'Myval THV series are novel next-gen THV devices; non-inferior to the Sapien and Evolut THV series. Myval THV series have a unique size matrix incorporating conventional, intermediate and extra-large diameters with increasing diameter steps of 1.5mm that match and fit precisely the multi slice CT scan-defined aortic annulus area of each individual patient, as a result, provides a superior effective orifice area on echocardiography, which may impact on durability and long-term clinical outcomes.

里程碑试验的主席兼研究主任Serruys教授说，“Myval THV系列是新一代THV设备；不劣于Sapien和Evolut THV系列。Myval THV系列具有独特的尺寸矩阵，包括常规，中等和超大直径，直径步长增加1.5mm，与每个患者的多层CT扫描定义的主动脉瓣环区域精确匹配，因此，在超声心动图上提供了优越的有效孔口面积，这可能会影响耐久性和长期临床结果。

Additionally, the Myval Octacor, with its 2 rows of octagonal cells and a minimal foreshortening of 19% during expansion, has unique features not paired by any other contemporary design.'.

此外，Myval Octacor拥有2排八角形细胞，在扩张过程中最小缩短了19%，具有其他当代设计无法比拟的独特功能。”。

Myval THV series has a versatile range of sizes offering not only traditional sizes (20 mm, 23 mm, 26 mm, 29 mm) but also intermediate (21.5 mm, 24.5 mm, 27.5 mm) and extra-large sizes (30.5 mm and 32 mm). This tailored sizing matrix allows cardiologists to select the appropriate valve size, thus avoiding excessive over- or under-sizing.

Myval THV系列拥有多种尺寸，不仅提供传统尺寸（20毫米、23毫米、26毫米、29毫米），还提供中等尺寸（21.5毫米、24.5毫米、27.5毫米）和超大尺寸（30.5毫米和32毫米）。这种定制的尺寸矩阵允许心脏病专家选择合适的瓣膜尺寸，从而避免尺寸过大或过小。

In the LANDMARK trial, 48.1% of the patients were implanted with the intermediate size of Myval THV series..

在具有里程碑意义的试验中，48.1%的患者植入了中等大小的Myval THV系列。。

The hemodynamic outcomes in terms of valve effective orifice area (EOA) was significantly better for the 23, 26 and 29 mm Myval THV series as compared to Sapien THV series, while there were no significant differences in the pre-procedural annular area. The long-term benefits of the intermediate sizes of THV will be further studied during the subsequent follow-up up to 10-year..

与Sapien THV系列相比，23,26和29 mm Myval THV系列的瓣膜有效孔面积（EOA）的血流动力学结果明显更好，而术前环形面积没有显着差异。在随后的10年随访中，将进一步研究中等规模THV的长期益处。。

As per the Global Principal Investigator, Prof. Andreas Baumbach, 'The Landmark trial showed that the Myval THV series performed as safe and effective as contemporary THV series. It is a valve made for everyday clinical practice and an all-comers population. The special feature of intermediate diameters allows for more accurate sizing, which has the potential to translate into improved long-term outcomes.

据全球首席研究员安德烈亚斯·鲍姆巴赫（AndreasBaumbach）教授介绍，“这项具有里程碑意义的试验表明，Myval THV系列与当代THV系列一样安全有效。它是为日常临床实践和全方位人群制造的阀门。中等直径的特殊功能允许更准确的尺寸，这有可能转化为改善的长期结果。

Our patients will be followed up for 10 years and it will be interesting to see the long-term results in the three treatment arms.'.

我们的患者将接受10年的随访，看到三个治疗组的长期结果将是有趣的。”。

Mr. Sanjeev Bhatt, Sr. Vice President - Corporate Strategy at Meril said, 'In a successful development in structural heart interventions, the LANDMARK RCT has revealed compelling results for the novel Myval transcatheter heart valve (THV) series, confirming its non-inferiority to other contemporary THV devices.

Meril公司战略高级副总裁Sanjeev Bhatt先生说，“在结构性心脏干预的成功发展中，具有里程碑意义的RCT揭示了新型Myval经导管心脏瓣膜（THV）系列的令人信服的结果，证实了其非劣于其他当代THV设备。

The results of LANDMARK trial are not just a win for us but for the entire medical community and, most importantly, for patients undergoing TAVI. This study not only reinforces the safety and efficacy of the Myval THV series but also highlights its adaptability to challenging anatomical structures'..

里程碑式试验的结果不仅是我们的胜利，也是整个医学界的胜利，最重要的是，对于接受TAVI的患者来说。这项研究不仅加强了Myval THV系列的安全性和有效性，而且突出了其对具有挑战性的解剖结构的适应性。。

About THE LANDMARK TRIAL:

关于里程碑式审判：

The LANDMARK trial was a prospective, randomized, multicenter, open-label, non-inferiority trial involving 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis. The first patient was enrolled in the LANDMARK trial on 6 January 2021 and the last patient was enrolled on 5 December 2023.

这项具有里程碑意义的试验是一项前瞻性，随机，多中心，开放标签，非劣效性试验，涉及768名接受经导管主动脉瓣植入术（TAVI）治疗主动脉瓣狭窄的患者。第一名患者于2021年1月6日参加了里程碑式试验，最后一名患者于2023年12月5日参加了试验。

The trial included a total of 768 patients at 31 sites across 16 countries (Brazil, New Zealand, and some countries of Europe). The 30 days primary composite endpoints reporting the safety and effectiveness of LANDMARK trial is accepted for publication in The Lancet..

该试验包括16个国家（巴西，新西兰和一些欧洲国家）31个地点的768名患者。报告LANDMARK试验安全性和有效性的30天主要复合终点被接受发表在《柳叶刀》上。。

About Meril Life Sciences:

关于Meril Life Sciences：

Meril is a leading global medical device manufacturing company based in India that has been pivotal in establishing India as a leader in the global medical devices industry. The company's strong focus on research and development (R&D) and commitment to quality have allowed it to offer cutting-edge medtech solutions in more than 135 countries.

Meril是一家总部位于印度的全球领先医疗器械制造公司，在将印度打造为全球医疗器械行业的领导者方面发挥了关键作用。该公司对研发（R＆D）的高度重视和对质量的承诺使其能够在135多个国家提供尖端的医疗技术解决方案。

Additionally, Meril has wholly-owned subsidiaries in the USA, Brazil, Australia, Asia, Africa and Europe..

此外，梅里尔在美国、巴西、澳大利亚、亚洲、非洲和欧洲拥有全资子公司。。

With its strong commitment to innovation and quality, Meril has transformed healthcare in India and created significant footprints across the globe. Through global partnerships and the use of advanced technology, the company prioritizes quality and adherence to international standards, fostering a thriving R&D environment.

凭借对创新和质量的坚定承诺，梅里尔已经改变了印度的医疗保健，并在全球范围内创造了重要的足迹。通过全球合作伙伴关系和先进技术的使用，该公司将质量放在首位，并遵守国际标准，营造一个繁荣的研发环境。

Meril's efforts have effectively established India as a centre for medical device innovation and production..

梅里尔的努力有效地将印度确立为医疗器械创新和生产中心。。

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