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.
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