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Design, Development, Testing at ISO Standards and In Vivo Feasibility Study of a Novel Polymeric Heart Valve Prosthesis

Tuesday, June 30, 2020

Submitted by

Wei-Guo Ma

Source

Source Name: Biomaterials Science

Source URL: https://pubs.rsc.org/en/content/articlelanding/2020/bm/d0bm00412j

Author(s)

Joanna Stasiak, Marta Serrani, Eugenia Biral, James Taylor, Azfar Zaman, Samantha Jones, Thomas Ness, Francesco de Gaetano, Maria Laura Costantino, Vito Domenico Bruno, M.-Saadeh Suleiman, Raimomdo Ascione, Geoff Moggridge

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.