A safe and effective replacement valve for treating severe Tricuspid Regurgitation and preventing Right Ventricle dysfunction
About 17 million people die each year from cardiovascular diseases (CVDs), a number that is expected to grow to more than 23 million by 2030. Of these deaths, an estimated 7.4 million were due to heart disease, including heart valve disease (HVD) such as tricuspid regurgitation (TR). The golden standard methods for tricuspid valve diseases are standard open-heart surgery and transcatheter valve replacement. However, high-risk interventions require long recovery time long in-hospital stays and have significant hospital mortality (more than 10%). Transcatheter tricuspid valve replacement (TTVR) is still ineffective due to the increased risk of side effects in right ventricle making this solution not available on the market. TriSol is introducing the TriSol System, a heart valve replacement system for treating severe TR and preventing RV dysfunction which usually follows tricuspid valve surgery. A flexible delivery system allows to position the valve into the heart through support arms for anchoring to the tricuspid physiological site. The entire procedure is performed in a medical center and takes up to 30 minutes compared to 2-4 hours of standard surgery. Trisol System will allow cardiologists to perform a quick and safe implant procedure thus increasing the number of treated population and reducing in-hospital and recovery time. Moreover, it will increase heart performance and reduce the risk of mortality typical of open-heart surgeries. During the feasibility assessment, a go-to-market strategy and a supply chain will be established, as well as further development plan will be drafted. During the second phase of innovation project, TriSol will upgrade the valve and delivery system components of TriSol system for application in multiple valve conditions such as mitral valve regurgitation. It will also increase the production line up to 4k per year. Multiple clinical trials will then be initiated for obtaining CE mark as a medical device.