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Questions Linger on Long-Term Benefits Even as Meril's Myval THV Series Gains Global Recognition

Meril Life Sciences' Myval Transcatheter Heart Valve (THV) Series received major attention at EuroPCR 2024, with the LANDMARK trial demonstrating its promise in the heart valve market, but some critics are yet to be convinced about the long-term viability.

The trial, which comprised 768 patients from 31 sites, validated the Myval THV Series' safety and efficacy, positioning it as a key late-breaking experiment at EuroPCR 2024. Professor Serruys, Chairman and Study Director of the Landmark study, described the Myval THV series as a promising next-generation device, citing its distinct size matrix and bigger effective orifice area.

The study results showed that the Myval THV series performed similarly to contemporary THV devices in terms of primary composite endpoint occurrence and secondary endpoints.

Commenting on the development, Sanjeev Bhatt, Senior Vice President of 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. The results of the 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.".

However, while the short-term results appear good, reservations remain about the Myval THV series' long-term benefits. Professor Andreas Baumbach, Global Principal Investigator of the experiment, emphasised the necessity for additional follow-up to examine long-term findings, particularly given the specific characteristics of intermediate diameters and their possible impact on patient outcomes over time.

Critics contend that, while the Myval THV series provides novel size possibilities and hemodynamic benefits, its true efficacy in improving long-term clinical outcomes remains unknown. As study participants are observed for up to ten years, the medical world expects clear proof on the long-term benefits of this revolutionary technology.

While Meril welcomes the acceptance of its Myval THV series at EuroPCR 2024, the medical community is cautiously optimistic, waiting for sufficient long-term data to support its safety and efficacy claims in everyday clinical practice.

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