CE Mark for Myval transcatheter aortic heart valve

Meril Life Sciences, a company based in India, has obtained the European CE mark of approval for its Myval transcatheter aortic heart valve. This marks the first such approval for an Indian company, highlighting how far the country’s medical device industry has advanced in the past few years.

The Myval features a hybrid honey comb design that can be seen using fluoroscopy, which helps to position the valve precisely within the lumen. It is delivered using the company’s Navigator system that has dual-stoppers that guarantee proper crimping of the valve and its safe journey to the deployment site. The CE clearance was based in part on the results of a 1 year clinical trial of the valve, which showed 100% success during deployment and no device-related cases of mortality. Moreover, none of the patients had to receive pacemakers nor were there any observed strokes or paravalvular leaks. Overall, quality of life was improved for the patients and the valve maintained performance evenly throughout the one-year study.

The unique crimping geometry of Myval ensures precise orthotopic device placement without any deep throating into the LVOT. This precise annular placement ensures that there is no conduction system disturbances thus eliminating need for a new pacemaker as seen with previous technologies. The post-procedure mean aortic gradient, peak aortic gradient, and peak aortic velocity remained consistently low till the time of follow-up. There was a significant improvement in NYHA Class among patients after the procedure. Also, no post-procedure re-intervention was required during the follow-up up to 6 months.