Gaetano is Chair of Bioengineering at UCL (UK) and Group Leader of Bioengineering at Ri.MED Foundation (Italy).  He studied Mechanical Engineering at the University of Palermo (Italy) and completed his PhD in biomechanics on a joint project between the same university and the University of Sheffield (UK), where he was then appointed Research Associate.  Subsequently, he joined SorinGroup (now Corcym) as Research Manager, before taking his position at UCL.  His main research interests lie in the field of cardiovascular engineering and medical devices development, where Gaetano has made major progresses that have found application into largely adopted therapeutic approaches.

Design, development and preclinical validation of a novel transcatheter aortic valve concept

This talk describes the design, development and preclinical assessment of a new polymeric aortic valve suitable for transcatheter implantation.  The device consists of three polymeric leaflets and an adaptive sealing cuff, supported by a fully retrievable self-expanding wire frame made from superelastic NiTi alloy.  A parametric design procedure based on numerical simulations was implemented to identify design parameters providing minimum stress levels and operating energy for the valve leaflets.  The wireframe was optimised to minimise the stress levels during valve delivery and provide adequate anchoring.  Valve prototypes were manufactured by thermomechanical processing of the NiTi wire and automated dip-coating of the polymeric components.  The hydrodynamic performances of the valves were assessed in a cardiac pulse duplicator, in compliance with the ISO5840-3 standard, and compared to two reference valves suitable for equivalent implantation ranges.  A valve prototype was implanted in orthotopic position of an acute ovine model, confirming retrievability, secure valve anchoring, adequate leaflets motion, and no interference of coronary flow or mitral valve function.
The proposed valve system demonstrated excellent hydrodynamic performance with significant reduction in paravalvular leakage and the potential to mitigate complications related to imprecise valve positioning.  This new concept may offer a safer and more economical TAVI solution to a broader range of patients.