Mitral Valve Repair System to Percutaneously Treat Moderate to Severe Regurgitation Using Alfieri Edge-to-Edge Technique

The MEDFREE® Valve Repair System will innovatively improve upon the current market leading MitraClip device, while leveraging and building on the proven percutaneous Alfieri edge-to-edge repair technique. We aim to address this vastly unmet percutaneous structural heart market by delivering a simpler, easier-to-use device in a smaller 12 Fr catheter system that can be used by a single operator.Public Health Relevance Statement/Project Narrative Mitral valve regurgitation affects more than 7 million people or about 2-3% of the population in the United States alone, of whom about 3.8 million suffer from moderate to severe regurgitation, as high as 1.7 million patients are in need of treatment and about 250 thousand patients get added each year [6, 10, 11, 15]. However, only about 50 thousand undergo surgical treatment each year due to the high risk associated with the procedure [11, 15] and although significantly safer, only about 15 thousand undergo catheter based interventional treatment, as the currently available interventional procedures are extremely difficult to perform [1, 14, 16]. In this project, MEDFREE® Inc., will build a safe, easy to use and innovative 12Fr percutaneous catheter-based interventional device that leverages the Alfieri edge-to-edge technique to address this severely unmet clinical need, which is a market that is conservatively estimated to grow from around $2 billion USD in 2018 to over $3 billion USD by 2022 [21].