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Cardiovalve has developed a novel transfemoral transcatheter heart valve replacement system for both mitral and tricuspid valves. The device avoids open-heart surgery by using a minimally invasive approach. It has shown promising early clinical results with high procedural success rates and durable implants maintaining clinical benefit for over two years in initial patients. The system received FDA Breakthrough Device designation for the tricuspid indication and has ongoing early feasibility studies in the US and Europe[2][5].
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