World-first surgery uses Aussie biopolymer in heart valve implant

An agency that developed biomedical polymers for cardiac pacemakers and polymer bank notes has just played a key role in what’s being called the world’s first polymer-based aortic heart valve implant.

Jointly developed by CSIRO – Australia’s national science agency – and U.S.-based medical device company Foldax, the Tria heart valve combines a patented design with CSIRO’s LifePolymer brand advanced biopolymer material.

The valve reportedly can last decades without calcification, risk of clotting or causing damage to red blood cells.

The valve was implanted during surgery conducted at Beaumont Hospital in Royal Oak, Mich. on July 30, and is part of an FDA early feasibility study for the treatment of aortic valve disease. The recipient is a 68-year-old man described in news reports as an ideal candidate “because he was physically fit and an avid runner.” The patient has since been discharged from 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. According to the World Health Organization, heart valve disease affects an estimated 30 million people in the general population of industrialized countries.

Headquartered in Salt Lake City, Utah, Foldax plans to complete enrollment in the early feasibility study at Beaumont Hospital, as well as at two other sites, this year. The proprietary biopolymer material and design of the Tria heart valves allows for high volume manufacturing, Foldax said, with the valves being robotically manufactured to provide high levels of quality and precision and allow for future patient customization, while eliminating the variability of human production.

“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 Foldax’s executive chairman, Ken Charhut. “What makes this so different from other heart valves is that we were able to design the valve to mimic the native valve.”

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.

Beyond heart valves, the LifePolymer material has other potential uses such as coatings for stents, vascular grafts or synthetic membranes for repair of ear drum ruptures, CSIRO said.