Meril got CE and CDSCO approval based on results of MyVal-1 Study: One-year clinical outcomes from study demonstrated 100 per cent acute procedural success
Meril’s Myval received CE approval to market and distribute its indigenously TAVR technology, Myval -THV system, to European Union and other countries. The CE certification is a conformity mark indicating the product to be compliant with the European Union (EU) health standards. The CE certification would enable Myval -THV to reach over 60 countries in Europe and outside of India which accept CE mark document for their own regulatory approvals.
Meril Life Sciences got CE and Central Drugs Standard Control Organisation (CDSCO) approval for Myval technology basis the results of MyVal-1 Study. One-year clinical outcomes from the MyVal-1 study demonstrated 100 per cent acute procedural success and no device-related mortality as reported at EuroPCR 2019 (May 21-24).
The data were presented in a late-breaking trial session at EuroPCR’2019 Conference at Paris by the trial’s principal investigator, Dr Ashok Seth, Chairman, Fortis Escorts Heart Institute, New Delhi explained that in addition to the procedural success and zero device-related mortality rate, there were also no new pacemaker implantations, no strokes and no para-valvular leaks observed in the trial patients. Furthermore, echo parameters were maintained at 12-month follow-up and there was a significant improvement in quality of life of the patients as demonstrated by tests including NYHA functional class.
Commenting on the proud moment Sanjeev Bhatt, Vice President Corporate, Strategy, Meril Life Sciences said, “We are excited by these results. Since its inception, Meril has played a leading role in developing and introducing innovative medical technologies. Our Myval Transcatheter Heart Valve technology is an assertion of this fundamental belief and after being granted the CE mark, we get set to launch it across Europe. It’s a proud moment not just for us but for India to be able to make this indigenous innovation available globally.”
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