MyVal-1 Study is a Prospective, Multicentre, single-arm, open label study of Myval-THV for the treatment of severe symptomatic native aortic valve stenosis. MyVal-1 Study has successfully completed the primary endpoint demonstrating high safety and efficacy at 30-days, 6-months, and 1 year.
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 upto 6 months.