Foldax has announced publication of the first clinical results for its Tria biopolymer heart valve, which the company describes as the first polymer valve to be implanted in humans.
The early feasibility study showed that the Tria surgical aortic valve met all of its primary endpoints at one year, including improvement in valve effective orifice area (EOA), clinically significant improvement in New York Heart Association (NYHA) class and safety. The data was published in the December 2021 issue of the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
The Tria valve combines the company’s proprietary biopolymer—LifePolymer—with a valve design that is intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without requiring lifelong use of anticoagulants.
“The heart valve options we have today are not perfect. Mechanical valves require daily use of anticoagulants that may infringe on patient lifestyles and are associated with significant bleeding complications, while tissue or bioprosthetic valves have limited durability. The biopolymer valve we studied offers the potential to improve patient outcomes, as the polymer and design work together to optimise the properties and performance of the valve leaflets,” said Dean Kereiakes, lead author on the publication and president of The Christ Hospital Heart and Vascular Institute at The Christ Hospital Health Network in Cincinnati, USA
Summarising the study results, Kereiakes said: “The Tria valve demonstrated marked and sustained improvements in transvalvular gradients, valve EOA and NYHA clinical class out to one-year following valve implant. Safety outcome measures appear comparable to those reported for bioprosthetic (animal tissue) heart valves.”
Detailed one-year results from the early feasibility study showed the following:
- Mean pressure gradients improved from an average of 33.3mmHg at baseline to an average of 9.5mmHg at one year
- Effective orifice area Increased from 1.2 cm2 at baseline to 2.0 cm2 at one year
- Patients’ NYHA classification was improved and sustained, with 66.7% of patients designated Class I at one year versus 33.3 percent at baseline
- No patients were NYHA Class III or IV at one year
- There were no device-related deaths
The early feasibility study of the Tria surgical aortic heart valve encompassed 15 patients studied at five sites in the USA. The US Food and Drug Administration (FDA) approved an expansion of the study to a total of 40 patients based upon review of the initial outcomes.
“We are pleased that the Tria valve demonstrated the excellent haemodynamics it was designed to achieve and that we expected to see in its first clinical study,” stated Frank Maguire, chief executive officer of Foldax.
The company’s second device, a mitral surgical valve, was approved by the FDA for a US early feasibility study earlier this year and is currently enrolling patients. The third valve product is a transcatheter aortic valve implantation (TAVI) device, which is in the pre-clinical testing phase.
The Tria heart valve is considered investigational in the USA and is not available for commercial sale in the USA.