Ashok Seth (New Delhi, India) talks to BLearning at EuroPCR 2019 (21–24 May, Paris, France) about the MyVal-1 study which looked at the one-year clinical outcomes of India’s first indigenously designed and manufactured TAVR system. This was the first in-human study of the device which was performed as per the regulatory authorities of India.
Seth outlines the key findings from the one-year data which showed that survival – which was the primary endpoint of the study – was 85% in those patients who were intermediate and high risk for surgical valve replacement. This, claims Seth, is the “normally expected survival rate of the best of the valves at one-year”.
There were no device-related complications or mortality, says Seth, who notes that “on all fronts the valve performed well and met the endpoints of safety and efficacy”. Increased innovation in India and emerging countries, he adds, can help bring down the cost of TAVR procedures on a global scale.