Foldax announced today that the first 30 patients have been treated outside the U.S. with its Tria polymer surgical mitral heart valve.
The procedures took place as part of the commencement of a clinical trial in India. Tria remains investigational and not available for commercial sale.
Salt Lake City-based Foldax designed Tria to accommodate the anatomy and pressures of the mitral position. It combines the company’s proprietary LifePolymer with a valve design for resisting calcification. The company says its valve withstands stresses and strains without failure, restoring quality of life without lifelong anticoagulant use.
According to Foldax, currently available prosthetic valve options for treating mitral valve disease have limitations. Those include issues with durability for tissue valves made from porcine or pericardial tissue. Additionally, some countries — like India — have cultural boundaries that restrict such valves. Foldax says mechanical valves limit quality of life due to their noise. They also may require lifelong blood-thinning medication.
More about the Foldax Tria valve and clinical trial
Avi Sharma, VP of clinical programs at Foldax, said there remains “a huge need” to treat such patients in India. Sharma said the company has seen rapid trial enrollment and promising results in treated patients to date.
“There is a huge need to help people suffering from mitral valve disease in India,” Sharma said in a news release. “The impact of the disease can be very limiting for many, especially younger patients, as there is currently no ideal heart valve replacement solution. In the case of young women, the impact can be devastating to their hopes of having a family. This polymer valve holds the promise of being a lifetime valve, without the negative quality-of-life implications of other types of prosthetic valves.”
The prospective trial in India expects to enroll up to 70 adult patients across 10 sites to support commercialization. Enrolled subjects have mitral valve disease, Foldax said. The trial evaluates valve hemodynamic and durability performance at six months and one year.
“We are excited to be able to offer our novel Tria mitral surgical valve to patients in India. We are grateful for the collaboration between the U.S. and Indian surgeons to identify patients who are candidates for the trial,” said Foldax CEO Gregory Casciaro. “As the Tria polymer valve is manufactured robotically with a small manufacturing pod footprint, we intend to make our valves available easily and efficiently, anywhere in the world, without the need for a large skilled workforce or large manufacturing facilities.”