Early stage cardiovascular device company Foldax said today it won FDA investigational device exemption approval to launch an early feasibility study of its Tria surgical aortic heart valve.
The valve uses a proprietary biopolymer material, dubbed LifePolymer, as well as a proprietary design, the Salt Lake City-based company said.
Foldax touted that the Tria heart valve is intended as a “lifetime valve,” adding that it can provide hemodynamic performance and quality of life similar to natural human valves without the use of animal tissue or need for long-term anticoagulants.
The Tria valve is intended for use in both transcatheter or surgical heart valve operations, and are robotically manufactured, the company said.
“We look forward to introducing the Tria heart valve to patients in the United States. With the Tria heart valve we have the opportunity to overcome the challenges with today’s heart valves. The Tria valve is truly a revolutionary option for the more than one million Americans who have moderate or severe heart diseases,” trial primary investigator Dr. Amit Patel of the University of Utah said in a prepared statement.
Foldax said that its Tria heart valve platform is slated to include valves designed for use in treating aortic, mitral and tricuspid valve disease, with plans to continue development efforts and clinical trials of the devices in pursuit of regulatory approvals.
“The FDA IDE approval to proceed with clinical investigation of the Tria heart valve represents a significant milestone for the company. It is the first step in bringing a 21st Century solution to patients with valve disease. Our goal is to transform the way heart valves have been made for the last 40 years by bringing high quality, value and patient specific options to clinic,” exec chair Ken Charhut said in a press release.
