Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve
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.
- 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 companys 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.