The TAVR race might be closer to having another competitor in North America, after the LANDMARK trial’s one-year results suggest that Meril’s Myval THV series achieved comparable clinical efficacy to both Edwards’ Sapien and Medtronic’s Evolut AVR systems.
- So far, the TAVR market has been dominated by established balloon-expandable (Sapien) and self-expanding (Evolut) valve systems.
- Myval THV is a balloon-expandable system that features a hybrid honeycomb design for better hemodynamic performance and minimizing paravalvular leak.
- While Meril’s Myval has gained CE mark in the E.U. the device is still undergoing the FDA’s premarket approval process in the U.S.
The LANDMARK trial enrolled 768 patients with symptomatic severe aortic stenosis at 31 sites across 16 countries, randomizing them to the Myval, Sapien, or Evolut systems and found that…
- Composite clinical efficacy (freedom from all-cause mortality, stroke, and hospitalization) was 87% for Myval versus 86.9% for both Sapien and Evolut, demonstrating statistical noninferiority.
- Extended clinical efficacy including quality-of-life deterioration showed consistent results: 80.5% for Myval, 75.0% for Sapien, and 79.7% for Evolut.
- Myval demonstrated the lowest moderate aortic regurgitation incidence at 1.6%, which is a marker of hemodynamic stability and long-term valve performance.
- In small aortic annulus patients, composite efficacy was similar: 91% for Myval versus 89% for Sapien and 91% for Evolut.
In a field dominated by established platforms with decades of experience, Meril believes that LANDMARK provides comparative insight by evaluating the valves against two leading systems under identical conditions.
- Specifically, Myval’s low aortic regurgitation rate is important as TAVR expands to younger, lower-risk patients who need durable long-term outcomes.
The trial’s investigators have also committed to a 10-year follow-up study to provide critical durability data, since valve longevity is becoming increasingly important for treatment decision-making.
- This means that the trial’s geographic diversity and inclusion of challenging anatomies like small annulus will strengthen the long-term data’s real-world generalizability.
The Takeaway
Though it’s only one year worth of results from LANDMARK, the early data suggests that Meril’s Myval performs similarly to incumbents and it might have a slight edge in hemodynamic stability. That said, the device still has a decade of data to catch up to from its competitors, so we’ll need to wait and see until its FDA approved before jumping to conclusions.
