Latest news with #Meril
Hans India
2 days ago
- Health
- Hans India
Meril Launches MyClip, India's First Transcatheter-Edge-to-Edge Repair (TEER) System for Treatment of Severe Mitral Regurgitation
Meril Life Sciences, a leading global med-tech company, marked a significant milestone with the launch of MyClip, India's first Transcatheter Edge-To-Edge Repair (TEER) system, on June 14. The landmark Structural Heart Innovation event, held at Meril Academy, Vapi (Gujarat) from June 13–15, brought together over 150 Indian interventional cardiologists along with cardiac imaging expert and international stalwarts, including Prof. Ottavio Alfieri ('Father of mitral valve repair'), Prof. Francesco Maisano, and Prof. Agricola, joining global pioneers in edge-to-edge mitral valve repair. Meril is currently the world's leading TAVI group following the success of Myval THV and first Indian company to introduce a TEER system, placing the country firmly on the map as an innovator in transcatheter heart valve therapies (with both replacement and repair technology platforms). MyClip introduction demonstrates India's growing capabilities in structural heart solutions and reflects Meril's commitment to accessible cutting-edge cardiac care. MyClip TEER System is designed for patients suffering from severe Mitral Regurgitation (MR) who are at high surgical risk due to pre-existing issues like hypertension, diabetes, obesity, advanced age, physical frailty, enlarged or weak heart, and patients with kidney, lung and liver problems. MR, particularly if untreated, has a devastating mortality rate—over 50% of patients may not survive without timely intervention, and 1-year mortality can be as high as 57%. The MyClip TEER System enables precise closure of the mitral valve flaps, effectively preventing the backward flow of purified blood into the lungs. The procedure is minimally invasive, & takes approximately one hour, and allows patients to return home within 3–5 days. After discharge, patients can resume daily activities like walking and non-strenuous work within a short period post the procedure. According to the landmark COAPT Study published in the New England Journal of Medicine (NEJM), patients receiving device-based therapy for mitral regurgitation experienced significantly better outcomes compared to those receiving standard medical treatment. Within 24 months, the hospitalization rate for heart failure was reduced to 35.8% per patient-year in the device group, compared to 67.9% in the control group. Additionally, mortality within the same period was notably lower in the device group, at 29.1%, compared to 46.1% in the control group. Currently, approximately 150 TEER (Transcatheter Edge-to-Edge Repair) procedures are performed annually in India, with the majority of patients falling in the younger age group (30 – 60). These statistics bring to light a pressing need for early and effective intervention in younger demographics. The launch of MyClip TEER System marks a transformative moment for structural heart therapy in India. Transcatheter Edge-to-Edge Repair (TEER) therapy has shown significant success over traditional Guideline Directed Medical Therapy (GDMT). MyClip represents a major step forward in India's cardiovascular treatment landscape. In his inaugural speech, Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril Life Sciences, said, 'In India, around 1.5 million people are known to have severe mitral regurgitation. Of these at least 1.2 million are post myocardial infarction (MI or a heart attack) or due to heart failure. Introduction of the MyClip TEER system marks a pivotal shift and we're witnessing early adoption. Meril's efforts in training cardiologists and building TEE-based imaging expertise are crucial steps in scaling this life-saving therapy across the country." 'With MyClip, Meril is reshaping the country's role in global medtech. This homegrown innovation is a testament to what Indian science, engineering, and clinical collaboration can achieve together. Meril's nationwide public awareness campaign #TreatmentZarooriHai is in full swing, with brand ambassador MS Dhoni, to educate patients and families about the life-saving value of timely intervention in mitral valve regurgitation,' Bhatt added. The two-day Structural Heart Innovation scientific program featured case demonstrations, interactive hands-on workshops, and the presentations leading Interventional Cardiologists and Echocardiologists. The event concluded with a call to build a sustainable M-TEER ecosystem in India, focused on accessibility, clinical excellence, and continuous innovation.
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@
