Second Product from Tria Biopolymer Valve Portfolio to Move into Human Study SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced the successful first-in-human use of its biopolymer Tria™ heart valve in surgically replacing a diseased mitral valve. The first case was performed by David Heimansohn, MD, at Ascension St. Vincent Hospital, […]
Tag: LifePolymer
Foldax Biopolymer Shown to Possess Ideal Properties for Heart Valve in New Published Paper
Company’s LifePolymer Material Used in First Polymer Heart Valves Ever Approved by FDA for Use in Clinical Trials SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced publication of a research paper in Advanced NanoBiomed Research that concluded that its LifePolymer™ biopolymer “exhibits ideal biomaterial properties for the flexible leaflets of a totally synthetic […]
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 […]
Foldax®, Inc. Successfully Completes First-In-Human Use of Next-Generation Tria Polymer Heart Valve for the Treatment of Aortic Valve Disease
SALT LAKE CITY–(BUSINESS WIRE)–Foldax, Inc. today announced its first-in-human use of the Tria heart valve under its FDA Early Feasibility Study (EFS) for the treatment of aortic valve disease. Clinicians at Beaumont Hospital, Royal Oak, in Michigan, implanted this innovative flexible polymer heart valve, which has the potential to address […]
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