Foldax today announced first-in-human use of its Tria heart valve in an FDA early feasibility study for the treatment of aortic valve disease.
The procedure was performed July 30 at Beaumont Hospital in Royal Oak, Mich. The patient is “doing well and has been discharged,” Beaumont chief of cardiovascular surgery Dr. Marc Sakwa said in a news release. The FDA gave the green light for the early feasibility study in February.
Salt Lake City-based Foldax’s Tria heart valve is constructed with LifePolymer, a biopolymer material, and robotically manufactured. The replacement valve is designed to address the durability and thrombogenicity issues of current heart valves that use animal tissue valves and/or are manufactured through human production.
The company said the complete Tria heart valve platform will include valves designed for use in aortic and mitral valve disease with transcatheter and surgical applications. Foldax plans to complete enrollment in the early feasibility study at Beaumont Hospital, as well as at two other sites, this year.
“The start of our EFS study in the U.S. represents a major milestone for Foldax and heart valve patients worldwide since Tria valves represent true next generation technology,” executive chairman Ken Charhut said in prepared remarks. “The Aortic EFS combined with our progress toward mitral and transcatheter versions of the valves next year have the potential to revolutionize the heart valve industry. We are bringing 21st century solutions to the worldwide problem of providing high quality products at an affordable price.”
Original Article: (https://www.massdevice.com/foldax-touts-fih-procedure-for-tria-polymer-heart-valve/)