MATERIAL Project

MATERIAL: Modeling structural vAlve deterioration for TranscathEteR mItrAL devices

Modeling structural valve deterioration for transcatheter mitral devices

MATERIAL

Michele Conti (Department of Civil Engineering and Architecture, Univeristy of
Pavia, Principal Investigator); Michele Marino (Department of Civil and Informatic
Engineering, University of Rome "Tor Vergata”, substitute Principal Investigator).

2025-2026 (24 months)

Transcatheter mitral valve replacement (TMVR) is the new frontier for minimally invasive
prosthetic heart valves, which must have long-term performance. To verify this, in-vivo
animal studies and bench-top experiments are used, which however usually require high
costs. In-silico analyses and predictive models can reduce such costs, speed-up design
iterations and testing phases, support a close-loop interaction between testing and design,
and accelerate devices translation to market. However, current computational models are
oversimplified and drop some crucial aspects to determine durability of a biological valve,
such as tissue features of pericardial leaflets, chemical treatments they undergo before
manufacturing process and occurrence of calcium deposition on the valve surface, which
can induce its failure.
MATERIAL goal is to develop in-silico simulations of TMVR to support durability assessments
of medical devices, as part of control activities performed in the risk assessment process.

Specific advancements targeted in MATERIALS comprise novel constitutive modeling
descriptions of fatigue mechanisms associated with structural valve degeneration, fed up by
ad hoc experimental campaigns and accounting for both the effects of fixation chemical
agents in the microstructure as well as macroscopic valve loading conditions. Although
developed for TMVR, the MATERIAL approach can be extended to the whole class of
percutaneous valves.