Meril’s Myval Octapro THV Launched in Europe

December 2, 2024—Meril Life Sciences, an India-based company focused on cardiovascular and structural heart solutions, recently announced the launch of its next-generation Myval Octapro transcatheter heart valve (THV), which has received CE Mark approval for transcatheter aortic valve replacement (TAVR).

According to Meril Life Sciences, the Myval Octapro THV is characterized by reduced frame foreshortening to enhance operator control and predictive deployment and a large size matrix composed of conventional, intermediate, and extra-large valve diameters for bioprosthetic valve sizing for individual patients. The Myval Octapro’s traditional sizes are 20, 23, 26, and 29 mm; intermediate sizes are 21.5, 24.5, and 27.5 mm; and extra-large sizes are 30.5 and 32 mm.

The company stated that the clinical efficacy of the Myval THV series was demonstrated in the 30-day primary outcomes from the LANDMARK randomized clinical trial (RCT) of Myval compared with contemporary THV devices. The prospective, multicenter, open label, noninferiority RCT was composed of patients who underwent TAVR for the treatment of aortic stenosis. The trial enrolled 768 patients at 31 sites across 16 countries including Brazil, New Zealand, and some countries in Europe.

In May, the company announced that the LANDMARK RCT findings were presented at the EuroPCR 2024 conference held May 14-17 in Paris, France. In June, the study’s early outcomes were published by Professor Andreas Baumbach, MD, et al in The Lancet (2024;403:2695-2708).

The primary endpoint of the LANDMARK RCT demonstrated noninferiority of the Myval THV series compared with a contemporary THV series.

In the trial, 48.1% of the patients were implanted with the intermediate size of the Myval THV series. The hemodynamic outcomes in terms of valve effective orifice area were significantly better for the 23-, 26-, and 29-mm Myval THV series as compared to the Sapien THV (Edwards Lifesciences) series, while there were no significant differences in preprocedural annular area, stated the company.

The company introduced the Myval Octapro device at GISE 2024, the 45th National Congress of the Italian Society of Interventional Cardiology held November 19-22 in Milan, Italy, and at the European Society of Cardiology’s PCR London Valves 2024 course held November 24-26 in London, United Kingdom.