Foldax this week announced that India’s medical device regulatory body approved initiation of a clinical trial to study its Tria biopolymer surgical aortic heart valve.
Salt Lake City-based Foldax designed the Tria heart valve to resist calcification, withstand stresses and strains without failure and restore patient quality of life without the lifelong use of anticoagulants.
The trial will study the ability of the biopolymer aortic valve to surgically treat patients with aortic valve disease and lead to commercial approval in India.
“After promising outcomes from our U.S. 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 commercializing our device outside of the U.S.,” CEO Frank Maguire said in a news release. “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 U.S.-based manufacturing.”
Foldax touts its Tria valve as being one of the first to be robotically produced, which is made possible due to its polymer leaflets that can be consistently manufactured with precise thickness and are designed to produce a valve with predictable lifetime performance.
The Tria heart valve is currently for investigational use only and is not available for commercial sale.