Background: Bioprosthesis has been increasingly implanted for the treatment of transvalvular disease across the world. A new Daffodil™ pericardial bioprosthesis (Meril Life Sciences Pvt. Ltd., India) recently approved by ConformitéEuropéenne (CE) is a tri-leaflet, stented, bovine valve. The purpose of the Daffodil-1 first-in-human trial was to evaluate clinical safety and performance (including hemodynamic parameters) of the Daffodil pericardial bioprosthesis in patients who underwent aortic or mitral valve replacement.
Methods: This prospective, multicenter clinical trial enrolled 60 patients (Aortic: 30 patients; Mitral: 30 patients) from seven sites across India. Safety endpoints were early (≤30 days) and late (> 30 days) mortality and valve-related morbidity. The performance endpoints were hemodynamic performance, improvement in NYHA functional class, and change in the quality of…
