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Design, Development, Testing at ISO Standards and In Vivo Feasibility Study of a Novel Polymeric Heart Valve Prosthesis
Researchers from the UK reported a novel polymeric heart valve, PoliValve, which is made entirely from styrenic block copolymers.
The unique feature of PoliValve is that it is made of a self-assembling polymer with a microstructure conferring mechanical anisotropy analogous to that of natural valve tissue. Its prototype substantially exceeds ISO standards for in-vitro testing and shows encouraging preliminary results in acute in-vivo feasibility/safety testing in sheep without anticoagulation. Postmortem confirmed intact structure of the PHV with no evidence of any acute valvular clot/thrombus. Its durability exceeded 1.2 billion cycles in accelerated in-vitro tests, equivalent to 30 patient years.
These results show that PoliValve is a promising alternative to traditional biological and mechanical valve prostheses, which lasts up to 30 years and does not need anticoagulation.