One-year data for the Myval transcatheter aortic valve implantation (TAVI) system indicate it is associated with 100% freedom from device related mortality at one year. These data, which were presented at EuroPCR 2019 (21–24 May, Paris, France) also showed that the valve was associated with 100% acute procedural success. The Myval device is a product indigenously designed and manufactured in India by Meril Life Sciences.
MyVal-1 study is a first-in-human, prospective, multicentre, single-arm, open label study of the Myval TAVI valve for the treatment of severe symptomatic native aortic valve stenosis which enrolled 30 patients and will follow-up out to five years. At 12-months, the study met its primary endpoint for safety and effectiveness: 100% procedural success, no major adverse events, and marked improvement from baseline to 12 months in quality of life scores (as measured by the six-minute walk test and the Kansas City Cardiomyopathy Questionnaire). Furthermore, 80.77% of patients were New York Heart Association (NYHA) class I and the remainder NYHA class II at 12-months, compared to 23.33% class I post-procedure.
According to a press release, Myval system is a balloon expandable transcatheter heart valve, made of nickel cobalt alloy frame. It has a hybrid honeycomb cell design, with open cells on the upper half to ensure unjailing of the coronary ostia and closed cells on the lower half for high radial strength. Additionally, Myval is equipped with an internal PET sealing cuff for lower profile and puncture resistance and an external PET buffing to minimise paravalvular leaks
Ashok Seth (Fortis Escorts Heart Institute, New Delhi, India), who presented the study at EuroPCR and was the principal investigator in the study, comments that in addition to the procedural success and zero device-related mortality rate, there were also no new pacemaker implantations, no strokes and no paravalvular leaks observed in the trial patients. Furthermore, echo parameters were maintained at 12-month follow-up and there was a significant improvement in the quality of life of patients as demonstrated by tests including NYHA functional class. “Based on these encouraging first-in-human results, further studies are being planned in a larger population and differing geographies for longer durations of time,” Seth says.
Imrankhan Lohani, Head Myval-THV Clinical Research at Meril Life Sciences, comments: “We are excited by these results. Our Myval transcatheter heart valve was granted the CE mark in April of this year. As we get set to launch it across Europe, we believe this valve from the emerging world is going to positively impact care substantially.”