The heart valve from Foldax is robotically made of polymers.
When these natural leaflets become diseased, they stiffen and impede blood flow. Individuals with diseased valves often require open heart surgery to replace the malfunctioning valve, for which they have had two options: a mechanical valve or a tissue valve.
Mechanical valves are crafted from synthetic materials such as pyrolytic carbon, and are the more durable option, but patients who get them must take blood thinners the rest of their lives to prevent blood clotting. Tissue valves, which are painstakingly hand-stitched from animal heart tissue (usually pigs) present less risk of causing clots and cellular damage but are less durable than mechanical valves, due to calcification and general wear-and-tear. Both are expensive options.
In contrast, the Tria valve uses a newly developed biopolymer, Lifepolymer, coupled with a bioinspired shape to create a valve that will last decades without calcification, risk of clotting, or damage to red blood cells. There are no animal cells or products. In testing, one valve already has lasted 600 million cycles, the equivalent of about 15 years, without significant wear-and-tear. Lifepolymer was key to the valve’s performance was developed in partnership with Australia’s national science agency.
The valve can replace diseased aortic, mitral, and tricuspid heart valves. It has a larger orifice area than conventional hand-stitched valves, and this creates hemodynamics and blood flow similar to natural human heart valves. The valves are also robotically manufactured for the highest levels of quality and precision, while eliminating the variability of human production
The next iteration of the valve, which Gharib has already designed in prototype with Foldax, can be inserted into the heart via a minimally invasive catheter.
