AorTech International (Dundee, UK) has published an update on its development of a polymer-based heart valve. The company issued a report noting progress in both the valve design and design for manufacture, which are said to be driving further improvements. Notably, the research has generated a substantial amount of intellectual property involving the relationship between defects in polymeric leaflets resulting from manufacturing limitations and valve durability. The design for manufacture project is driven by a desire to eliminate both the design limitations and potential for defects of dip casting, the company stated on its website.
While dip casting can be a successful method for the production of heart valves, it is very difficult to validate and achieve product consistency, thus placing a significant reliance on quality control inspections, said AorTech. The company believes that these limitations can be overcome by an alternative novel manufacturing process.
Because this method of manufacture may lead to the creation of valuable new intellectual property, AorTech said that it is unable to disclose any further details regarding the technology.
It has committed to the design and manufacture of bespoke equipment that will produce prototype valves for proof of concept. The specialist equipment has also been designed to allow valve production to be industrialized going forward.
The objective of the project, which is partly funded by the national economic development agency Scottish Enterprise, is to confirm the capabilities of the novel manufacturing technology, which will then be followed by process optimization, design freeze and a full set of ISO-compliant testing programs, said the company.
AorTech is the creator of biostable, implantable polymers, including Elast-Eon and ECSil, the world's leading long-term implantable co-polymers, which are manufactured on its behalf by Biomerics LLC in Utah. The materials’ biostability is comparable to silicone while exhibiting excellent mechanical, blood contacting and flex-fatigue properties, said the company. The polymers can be processed using conventional thermoplastic extrusion and molding techniques.
On a related note, another Utah-based company, Foldax, reported in September 2019 implantation of the first polymer-based aortic heart valve in a human. The Tria heart valve combines a patented design with a biopolymer developed by the Commonwealth Scientific and Industrial Research Organisation in Australia.