Compellon + Healthcare & Life Sciences

Process Manufacturing: Polymer Synthesis Interaction and Outcome

A client testimonial from the CEO of Foldax, Frank Maguire

Foldax® manufactures the Tria™ synthetic heart valve using a proprietary copolymer developed specifically for heart valve application by Australian Commonwealth Scientific and Industrial Research Organization (CSIRO). Foldax internally produces the polymer it needs for its various heart valve designs.

The synthesis of this silicone/urethane/urea composition trademarked as LifePolymer™ is a highly sensitive process requiring precise amounts of the various reagents comprising the polymer and tight control of reaction kinetics. Furthermore, the field of silicone/urethane copolymers is very narrow. There are few experts and a limited number of publications.

The polymer has been tested extensively prior to the FDA approval for its first human use in the Tria valve. Each new manufacturing batch is subjected to a battery of analytical chemistry and physical property testing. Polymer characteristics are monitored carefully. A database of reagents and process conditions is maintained for this purpose.

Because of the complexity of the LifePolymer synthesis and the limited amount of historical experience with it, the Compellon analytics are especially valuable in determining which components or process steps may be more influential than others in affecting the properties of the polymer. For example, analysis conducted using the Compellon tools has turned up relationships between polymer flexibility and one of the reagents. This outcome is indisputable yet represents a new understanding of reaction kinetics not previously understood by any member of the Foldax Scientific Advisory Board which includes the polymer’s inventor and a Nobel Laureate in Chemistry.

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About Foldax

Foldax, Inc. is taking the lead in the development of heart valves with the goal of improving hemodynamic performance similar to natural human valves. Driven by a passion to help patients, we collaborate with leading clinicians and researchers to design and manufacture heart valves intended to provide sustainable quality of life improvement for people with aortic, mitral or tricuspid valve disease. Learn more about Foldax, www.foldax.com