Jointly developed by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and Foldax® Inc, a leader in the development of polymeric heart valves, it is the first in the world to be made from a polymer and the first of its kind to be implanted in a human patient.
Next generation biomedical polymers
The Tria valve is made from a silicone-rich polyurethane polymer material. Its design and the polymer chosen mimic the natural human heart valve. The polymer is strong enough to withstand the constant and powerful pulsations characteristic of a healthy aortic valve. And it is capable of lasting for decades without suffering calcification or deteriorating red blood cells. Tria is designed to reduce or eliminate the need for a lifetime of anticoagulant drugs, and the strain, risks and side effects they cause. Flexibility, biological stability and biocompatibility... no more need for medication and only one operation is required.
Robotic valves for improved reliability and quality
The TRIA valves are the first and only heart valves to be manufactured robotically, reducing variability and allowing for high accuracy, repeatability and reliability, while substantially improving the economics of heart valve manufacturing.
A 68-year-old US patient received the first implant in late 2019 as part of an early FDA (Food and Drug Administration) feasibility study for the treatment of aortic valve disease. More than a year after his discharge from Beaumont Hospital in Royal Oak, Michigan, the initial clinical results of his procedure have been very satisfactory. The initial feasibility study of the TRIA surgical aortic heart valve, which included 15 patients studied at five sites in the US, was later expanded to a total of 40 patients based on the initial results.
Towards global expansion?
The next step is a more extensive study. “Following the promising results of our early feasibility study in the US, we are excited to expand our clinical study of the TRIA biopolymer valve globally, starting in India. This study is the first step in the commercialisation of our device outside the US,” said Frank Maguire, CEO of Foldax, in a press release. “Our robotic manufacturing process - which is unique among heart valve manufacturers - gives us an advantage when considering global expansion, as it allows us to manufacture in-country with the same precision and quality as in the US. We are able to produce our valves robotically because biopolymer leaflets can be consistently manufactured with precise thicknesses, unlike tissue valves; this process is designed to create a valve offering predictable performance throughout its lifetime.”
The World Health Organization estimates that aortic valve disease affects approximately 30 million people in the general population of industrialised countries.