Foldax has announced that the Drugs Controller General of India (DCGI), India’s regulatory body for medical devices, has approved initiation of a clinical trial of the Tria biopolymer surgical aortic heart valve.
The Tria valve combines the company’s proprietary biopolymer—LifePolymer—with a design intended to resist calcification and restore patient quality of life without lifelong use of anticoagulants.
The trial will study the ability of the TRIA biopolymer aortic valve to surgically treat patients with aortic valve disease and lead to commercial approval in India.
“After promising outcomes from our US early feasibility study, we are excited to expand our clinical study of the Tria biopolymer valve globally, beginning in India. This study is the first step to commercialising our device outside of the USA,” said Frank Maguire, chief executive officer of Foldax. “Our platform technology is well suited to one of the largest heart valve replacement markets in the world that has relied on mechanical heart valves to treat both aortic and mitral disease. The Tria valves are designed to be uniquely durable while sparing patients from the negative consequences of blood thinning medication. Additionally, our robotic manufacturing process allows us to consider in-country manufacturing with the same precision and quality as our USA-based manufacturing.”
The Tria heart valve is for investigational use only and is not available for commercial sale.