US-based cardiovascular device maker Foldax has received the Drugs Controller General of India (DCGI) approval to commence a clinical trial of its Tria aortic heart valve in India.

The company manufactures its Tria heart valves using an advanced biopolymer material, dubbed LifePolymer, and with a unique valve design for a predictable lifetime performance.

In the clinical trial, Foldax will evaluate Tria biopolymer aortic valve in surgically treating the patients with aortic valve disease. It is intended at gaining commercial approval for the valve in India.

Foldax chief executive officer Frank Maguire said: “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 commercialising our device outside of the US.”

According to the company, 70% of aortic valve replacement procedures are currently being performed in India, using implant mechanical valves.

Mechanical valves are long-lasting, but the patients require using anticoagulant to minimise blood clotting, for their entire life.

The long-term use of anticoagulants may create an ongoing bleeding risk, affecting the patient’s lifestyle, quality of life, and may lead to haemorrhage and death.

Foldax claimed that its Tria heart valves are design to repel calcification, endure stress and strain, and restore the quality of life, and eliminate the use of anticoagulants for patients.

Also, Tria is the first and only robotically produced heart valve, as its polymer leaflets allows consistent manufacturing with precise thicknesses.

Maguire added: “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.”

In December last year, Foldax has secured the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) for a clinical trial of its Tria heart valve in the US.