Published: Dec 14, 2020
SALT LAKE CITY (BUSINESS WIRE) Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.
The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and addresses a large unmet clinical need based on the prevalence of rheumatic fever worldwide.
The first of the company’s products – an aortic surgical heart valve – is currently enrolling a U.S. clinical study as a result of FDA approval of an expanded study last October. The third valve product is a transcatheter aortic valve replacement (TAVR), which is in the pre-clinical testing phase.
Foldax to Initiate FDA Clinical Study of Biopolymer Mitral Heart Valve
December 14, 2020 - Foldax Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) so the company to initiate a U.S. clinical study of its Tria biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.
The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and addresses a large unmet clinical need based on the prevalence of rheumatic fever worldwide.
Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve SALT LAKE CITY (Business Wire) Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria™ biopolymer mitral surgical heart valve. The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.
The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and addresses a large unmet clinical need based on the prevalence of rheumatic fever worldwide.