Myval Octapro THV, to be launched at GISE 2024 and London Valves 2024 conferences

The Myval THV series* has a profound impact & has been instrumental in advancing transcatheter aortic valve replacement (TAVR) therapy, making a significant positive impact on patients' lives. Characterized by reduced frame foreshortening leading to higher operator control and predictive deployment; availability of a large size matrix comprising of conventional, intermediate and extra-large valve diameters allowing better bioprosthetic valve sizing for individual patient and supported by a large pool of clinical evidence substantiates the day-to-day clinical utility of the device globally.

The clinical efficacy of the Myval THV series was demonstrated through the LANDMARK RCT published in THE Lancet (Baumbach et. al. Volume 403, Issue 10445, P2695-2708, June 22, 2024), conducted by renowned clinicians worldwide including 768 real world patients in 16 countries across 31 centers. The primary endpoint of the LANDMARK RCT demonstrated non-inferiority of the Myval THV series compared with contemporary THV series. Importantly, effective orifice area (EOA) of conventional sizes 23, 26, 29 mm of Myval THV series were significantly better than contemporary balloon expandable series. Moreover, 48% of Myval THV series implants were intermediate-size devices which are not offered by contemporary THV technologies. Both the intermediate and XL diameters are unique to context of TAVR technology. Myval THV series implants were intermediate-size devices which are not offered by contemporary THV technologies. Both the intermediate and XL diameters are unique to context of TAVR technology.

At Meril R&D the effort is to continuously identify current unmet clinical needs and keep next-generation technologies available so that clinicians globally can continue to offer Myval THV series to their patients suffering with severe aortic valve stenosis.

Meril acknowledges the recent decision by the Unified Patent Court (UPC) to enjoin its Myval Octacor THV system sales in certain EU member states. While Meril respects the judicial process, it firmly believes in the innovative value and integrity of its Myval Octacor THV technology. Meril is committed to appealing this decision with confidence and anticipates a favourable outcome that upholds the merits of its pioneering work in transcatheter heart valve systems.