Latest news with #MerilLifeSciences
Mint
24-05-2025
- Health
- Mint
Meril Presents One-Year Results of LANDMARK RCT at EuroPCR 2025
Vapi, 24th May 2025– Meril Life Sciences today announced one-year results from its pivotal LANDMARK trial, presented during the prestigious Late-Breaking Trial session at EuroPCR 2025,one of the world's premier cardiology conferences held annually in Paris, LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. The Myval THV series demonstrated non-inferiority to contemporary THVs in terms of 1-year clinical efficacy composite endpoint (Myval THV Series: 13% vs. Contemporary THV: 13.1%, difference: -0.1%, one-sided 95% CI: 3.9%, Pnoninferiority < 0.0001). Additionally, in the composite endpoint of clinical efficacy combined with QoL, outcomes were comparable (Myval THV Series: 19.5% vs. Contemporary THVs: 22.7%, difference: -3.2%, 95% CI: -9.2 to 2.9, P=0.33). Hemodynamic parameters including effective orifice area (EOA), mean pressure gradient (PG), and incidence of moderate or greater aortic regurgitation remained stable and similar across all treatment arms. Survival rates were nearly identical (Myval THV Series: 92.8% vs. Contemporary THVs: 92.9%), and QoL improvements were comparable, reinforcing the overall safety and durability of the Myval THV series in everyday clinical use. Professor Patrick Serruys,Chairman and Study Director of the LANDMARKtrial, said:'This trial reflects a new era in comparative valve research. The meticulous design and adherence to VARC-3 standards, including QoL endpoints, mark it as a pivotal study. The results of the LANDMARKtrial represent a meaningful advancement for the global structural heart community—and most importantly, for patients receiving TAVI. The data not only validate the safety and efficacy of the Myval THV series, but also spotlight its adaptability to complex anatomies. This versatility is exactly what clinicians need to deliver precision care across a broad spectrum of patients.' Meril Professor Andreas Baumbach,Global Principal Investigator, said: 'The LANDMARK trial represents a significant step forward in TAVI research. For the first time, we've benchmarked Myval against both balloon-expandable and self-expanding platforms in a rigorous randomized setting. The one-year results demonstrates that the new generation Myval THV series can match global standards in safety and efficacy.' Mr. Sanjeev Bhatt,Senior Vice President – Corporate Strategy at Meril, said:'The LANDMARKtrial represents a significant milestone not just for Meril, but for the global TAVI community. The strong one-year results affirm the Myval THV series as a next-generation solution that delivers consistent safety, clinical efficacy, and improved quality of life across geographies. As the only head-to-head trial of its kind to include both balloon-expandable and self-expanding valves, it reinforces Myval THV series's versatility and real-world relevance for diverse patient anatomies and healthcare systems. At Meril, we are proud to contribute innovative, evidence-based technologies that are reshaping patient care and expanding access to advanced structural heart therapies worldwide.' The trial is designed to follow patients for a period of 10 years, aiming to generate long-term insights into clinical and echocardiographic outcomes, with a focus on valve durability and sustained performance. The LANDMARKtrial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. The LANDMARKtrial 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 LANDMARKtrial on 6 January 2021 and the last patient was enrolled on 5 December 2023. The trial included a total of 768 patients at 31 sites across 16 countries (Brazil, New Zealand, and some countries of Europe). The 30-day primary composite endpoints highlighting the safety and efficacy outcomes of the LANDMARKtrial have been successfully published in The Lancet and EuroIntervention, two of the most prestigious peer-reviewed medical journals. Meril is a global medical device company based in India, committed to advancing healthcare through innovation. With a strong focus on research and development, Meril delivers cutting-edge medtech solutions across more than 135 countries and has a robust presence through subsidiaries in the USA, Brazil, Europe, Asia, Africa, and Australia. Through partnerships, precision technology, and adherence to international quality standards, Meril is helping reshape the future of healthcare. Note to readers: This article is part of Mint's paid consumer connect Initiative. Mint assumes no editorial involvement or responsibility for errors, omissions, or content accuracy. Want to get your story featured as above? click here!
Business Standard
22-05-2025
- Health
- Business Standard
Meril Presents Successful LANDMARK RCT One-Year Results at Prestigious EuroPCR 2025
PRNewswire Vapi (Gujarat) [India], May 22: Meril Life Sciences announced one-year results from its pivotal LANDMARK trial, presented during the prestigious Late-Breaking Trial session at EuroPCR 2025, one of the world's premier cardiology conferences held annually in Paris, France. The LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. The Myval THV series demonstrated non-inferiority to contemporary THVs in terms of 1-year clinical efficacy composite endpoint (Myval THV Series: 13% vs. Contemporary THV: 13.1%, difference: -0.1%, one-sided 95% CI: 3.9%, Pnoninferiority < 0.0001). Additionally, in the composite endpoint of clinical efficacy combined with QoL, outcomes were comparable (Myval THV Series: 19.5% vs. Contemporary THVs: 22.7%, difference: -3.2%, 95% CI: -9.2 to 2.9, P=0.33). Hemodynamic parameters including effective orifice area (EOA), mean pressure gradient (PG), and incidence of moderate or greater aortic regurgitation remained stable and similar across all treatment arms. Survival rates were nearly identical (Myval THV Series: 92.8% vs. Contemporary THVs: 92.9%), and QoL improvements were comparable, reinforcing the overall safety and durability of the Myval THV series in everyday clinical use. Professor Patri c k Serruys, Chairman and Study Director of the LANDMARK trial, said: "This trial reflects a new era in comparative valve research. The meticulous design and adherence to VARC-3 standards, including QoL endpoints, mark it as a pivotal study. The results of the LANDMARK trial represent a meaningful advancement for the global structural heart community--and most importantly, for patients receiving TAVI. The data not only validate the safety and efficacy of the Myval THV series, but also spotlight its adaptability to complex anatomies. This versatility is exactly what clinicians need to deliver precision care across a broad spectrum of patients." Professor Andreas Baumbach, Global Principal Investigat or, said: "The LANDMARK trial represents a significant step forward in TAVI research. For the first time, we've benchmarked Myval against both balloon-expandable and self-expanding platforms in a rigorous randomized setting. The one-year results demonstrates that the new generation Myval THV series can match global standards in safety and efficacy." Mr. Sanjeev Bhatt, Senior Vice President - Corporate Strategy at Meril, said: "The LANDMARK trial represents a significant milestone not just for Meril, but for the global TAVI community. The strong one-year results affirm the Myval THV series as a next-generation solution that delivers consistent safety, clinical efficacy, and improved quality of life across geographies. As the only head-to-head trial of its kind to include both balloon-expandable and self-expanding valves, it reinforces Myval THV series's versatility and real-world relevance for diverse patient anatomies and healthcare systems. At Meril, we are proud to contribute innovative, evidence-based technologies that are reshaping patient care and expanding access to advanced structural heart therapies worldwide." The trial is designed to follow patients for a period of 10 years, aiming to generate long-term insights into clinical and echocardiographic outcomes, with a focus on valve durability and sustained performance. About THE LANDMARK TRIAL: The LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis. 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. The trial included a total of 768 patients at 31 sites across 16 countries (Brazil, New Zealand, and some countries of Europe). The 30-day primary composite endpoints highlighting the safety and efficacy outcomes of the LANDMARK trial have been successfully published in The Lancet and EuroIntervention, two of the most prestigious peer-reviewed medical journals. About Meril Life Sciences: Meril is a global medical device company based in India, committed to advancing healthcare through innovation. With a strong focus on research and development, Meril delivers cutting-edge medtech solutions across more than 135 countries and has a robust presence through subsidiaries in the USA, Brazil, Europe, Asia, Africa, and Australia. Through partnerships, precision technology, and adherence to international quality standards, Meril is helping reshape the future of healthcare. Media Contact: media@
Time of India
19-05-2025
- Health
- Time of India
Hat-trick of TAVR procedures marks growing adoption of advanced heart valve treatment in city
Nagpur: The city is witnessing a significant leap in cardiac care with the increasing use of (TAVR) – a minimally invasive technique used to treat patients suffering from severe aortic stenosis who are unfit for open-heart surgery. In a notable milestone, three were successfully performed in a single day in a single operation theatre by a team of cardiologists in the city, marking a first for the region. Tired of too many ads? go ad free now TAVR offers a revolutionary approach where the diseased aortic valve is replaced via catheter-based technology without the need for open surgery or general anaesthesia. Patients remain awake during the procedure and typically resume basic activity within hours. Many are discharged the very next day – a sharp contrast to the prolonged recovery associated with conventional surgical methods. This development reflects the growing confidence in the technique and its acceptance among both doctors and patients. The procedures were performed using 'MyValve' by Meril Life Sciences, a company that has been instrumental in expanding access to TAVR across India. First introduced in Central India in 2018, TAVR slowly gained traction in cities like Nagpur, where awareness is still a challenge. Initially guided by proctors, cardiac teams in the region have now built the expertise to conduct these procedures independently. The recent back-to-back TAVRs were conducted without external supervision, showcasing local capacity-building in advanced cardiac care. Dr. Jaspal Arneja, Senior Interventional Cardiologist and Director of Arneja Heart Hospital—where the latest procedures were conducted—highlighted the life-saving potential of the technique: "One of the three patients was critically ill and underwent TAVR the very next day of admission. A few years ago, such a case would have poor chances of survival." Cardiologists Dr. Vivek Mandurke and Dr. Amar Amale also played key roles in managing and executing the complex procedures. Tired of too many ads? go ad free now Dr. Mandurke added, "As more people come to know about TAVR and its benefits, the demand will rise, potentially bringing down the cost of valves and making the treatment more accessible. We also foresee the use of artificial intelligence in early diagnosis and targeted treatment to further improve outcomes and reduce healthcare costs. " While the number of TAVR procedures is still relatively low in smaller cities compared to metros, the recent achievement signals a shift towards more widespread availability of cutting-edge heart treatments in Tier-2 regions like Nagpur.
