MyVal-1 Study is a Prospective, Multicentre, single-arm, open label study of MyVal-TAVR System for the treatment of severe symptomatic native aortic valve stenosis. MyVal-1 Study has successfully completed the primary endpoint demonstrating high safety at 30-days and 6-months driven by
100% device success
No device related death
No peri and post procedure stroke/TIA or MI
No new pace maker implantations
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 pace maker 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 study of 6 months.
MyVal-1 study became pivotal for Myval approval by CDSCO.
^Source: Dr.Ashok Seth presenting on behalf of MyVal-1 investigators at TCT 2018, USA
*700+ Patients to be studied under Myval Global Clinical Trial Program
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