Testing of Non Calcifying Mitral Bioprosthesis

Our aim is to test the performance in animals of an innovative stentless chordally supportedmitral valve designed to produce hemodynamics significantly superior to all existing devices, in vitrowear performance significantly exceeding current bioprosthesis, and treated so that calcification, in vivo,is inhibited and host endothelial covering occurs. The valve can be made quickly and cheaply. Thetesting will follow FDA Heart Valve Replacement Device Guidelines, so as to complete the requirementsfor application for an IDE and an Export License. Once the IDE & Export License are granted, clinicaltrials following the Guidelines will start in the U.S.A., and overseas. It is anticipated that the testing willconfirm the previous in vitro and in vivo results.