The first polymer-based aortic heart valve has been implanted in a patient, reported the Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Canberra, Australia, on Sept. 29. The Tria heart valve, manufactured by medical device manufacturer Foldax in Salt Lake City, combines a patented design with CSIRO's biopolymer material, LifePolymer. The valve reportedly can last decades without calcification, risk of clotting or causing damage to red blood cells.
The surgery conducted at Beaumont Hospital in Royal Oak, MI, is part of an FDA early feasibility study for the treatment of aortic valve disease. The recipient is a 68-year-old man who, the hospital said, was an ideal candidate “because he was physically fit and an avid runner.” The surgery was performed on July 30 and the patient feels so good “he wants to run a marathon,” said the hospital.
Aortic valve disease is a congenital or age-related condition where the valve between the main pumping chamber of the heart and the body’s main artery stops functioning properly. The World Health Organization estimates that heart valve disease affects around 30 million people in the general population of industrialized countries.
Valve implants typically are made from animal tissues or, in the case of mechanical valves, titanium and carbon. The Tria heart valve is the first one made from a polymer that has been implanted in a human patient.
“This is a true example of Aussie innovation going global, with our team in Melbourne designing, developing and scaling-up the new polymer," said CSIRO project leader, Dr Thilak Gunatillake." Foldax now manufactures the Tria heart valve for patients around the world in Salt Lake City, Utah."
Foldax Executive Chairman Ken Charhut said the world-first surgery represented a major milestone for the company. "Tria heart valves are revolutionizing the industry as the first and only biopolymer heart valve platform using LifePolymer material, eliminating the use of animal tissue," said Charhut. "What makes this so different from other heart valves is that we were able to design the valve to mimic the native valve."
The next-generation polymer has other potential uses such as coatings for stents, vascular grafts or synthetic membranes for repair of ear drum ruptures, added the CSIRO press release. The project team is in discussion with potential industry and research partners to apply the technology to other products.
CSIRO was also behind the development of Elast-Eon, which is used in cardiac pacemakers implanted in more than 10 million people worldwide, as well as polymer bank notes and extended-wear contact lenses.