Foldax has obtained the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) to commence a clinical study of its Tria biopolymer mitral surgical heart valve in the US.

The company said that the mitral valve offering is the second of the three Tria biopolymer heart valve products in its portfolio.

The first product, an aortic surgical heart valve, is currently enrolling participants in a US clinical study following an FDA IDE approval in October 2019. The third valve product is a transcatheter aortic valve replacement (TAVR), currently in the pre-clinical testing phase.

Beaumont Hospital Royal Oak, Michigan cardiovascular surgery chief and Foldax Medical Advisory Board head Frank Shannon said: “There is a great need for a more durable mitral valve, as tissue valves tend to be much less durable in the mitral position than in the aortic position, yet there have been very few mitral valve clinical studies in the past decade.

“The Tria biopolymer valve offers the potential to be an important new therapeutic option with enhanced durability that is intended to allow patients to avoid taking the blood thinning medication required by mechanical valves.”

Foldax to perform first in-human implantation of Tria biopolymer mitral valve in few weeks

Foldax said that the first use of its Tria biopolymer mitral valve in humans is expected in few weeks, and the new mitral valve offering will address a large unmet clinical need based on rheumatic fever prevalence.

Also, the Tria valve will incorporate a new, proprietary biopolymer, dubbed LifePolymer, with advanced valve designs to resist calcification, bear stresses and strains, and restore patient quality of life, eliminating the long-term use of anticoagulants.

The company claimed that its Tria is the first and only robotically manufactured heart valve that reduces variability and enables high precision, repeatability and quality, while improving the economics of heart valve manufacturing.

Foldax CEO Frank Maguire said: “We are gratified that the FDA has now approved two of our valves for clinical investigation. This latest approval is an important milestone in our mission to develop a portfolio of surgical and transcatheter biopolymer heart valves designed to last a lifetime.

“We view the Tria mitral valve as a product with global appeal that is capable of meeting the durability needs of both advanced and developing countries, while addressing the consequences of rheumatic fever and challenges of managing mechanical valve-related anticoagulation therapy in developing regions.”