Foldax: A Lasting Solution for Healthy Cardiovascular Functioning

The human heart consists of four biological valves called the pulmonary, tricuspid, mitral, and aortic valve; one for each chamber. Any damage to these delicate structures due to a disease or an accident can lead to various life threatening situations, which are obviously highly undesirable. Many medical device companies produce both biological and mechanical valves to help patients lead normal lives after their valves needed replacement. However, there is no ideal heart valve; biological tissue valves offer a better quality of life without anticoagulants, but have limited durability, and mechanical valves offer durability, but come with a lifetime of anticoagulation. It stands to reason that, while patients today are served well by the current options that exist in the marketplace, there is one patient group that does not enjoy similar privileges—those patients suffering with rheumatic fever, a disease related to the mitral heart valve. This is one of the biggest concerns the modern medical community has today, as the number of patients affected by rheumatic fever currently stands at nearly 33 million. When a person first contracts the disease, the issue may not seem dire at first. This alludes to the fact that rheumatic fever related mitral valve disease usually occurs nearly ten or 20 years after the actual illness. And now, instead of attacking the throat or causing a fever, the bacteria damage the mitral valve. The small, flap-like tissue in the heart is responsible for ensuring no backflow of blood, and if the valve fails, it may need to be replaced.

Today, Foldax, a medical device developer from Salt Lake City, has showcased a promising new product, called TRIA LifePolymer heart valve, that is designed to provide patients a lifetime of healthy heart function without the potential for multiple interventions—a better quality of life option than the traditional tissue & mechanical valves. However, the rheumatic fever mitral replacement needs remains an unmet need. “So, we see this valve as a worldwide valve, opening a solution to patients that didn’t exist before. Being able to get it into the clinic is super exciting for us.”

The issue with rheumatic mitral patients is that they tend to be in developing countries with less developed healthcare systems and have difficulty tracking and controlling anticoagulation levels. Moreover, since the procurement of effective anticoagulants is difficult in many parts of the world, the TRIA heart valve should prove to be extremely desirable in international marketplaces as well.