An estimated 60 million people, 20-25%, of the adult population in the United States alone are suffering from structural heart defects. These heart defects include patent forman ovale (PFO), atrial septal defect (ASD) and valvular disease. The European Union (EU), with a population in excess of 500 million inhabitants of which more than 88 million are over the age of 65, represents an even larger market for devices addressing structural heart repair.
Structural Heart Disease
Mitral Valve Disease
- 56% of the 5.2 failure in the United States have mitral regurgitation (MR).
- There are approximately 850,000 patients with severe MR in the US, with severe MR a contributing factor in an estimated 100,000 patient deaths per year.
- There is a $2B market opportunity for heart surgeries related to mitral valve disease.
The Tricuspid Valve: "The Forgotten Valve"
The patient population for tricuspid regurgitation (TR) is 1.6MM people in the United States alone. Approximately 50% of people with mitral regurgitation also have tricuspid regurgitation. 80% is functional TR. Operative mortality is 20% and morbidity is even higher. There is a large unmet clinical need for interventional TV procedures due to the unfavorable surgical risk profile of these patients.
NOTE: All source data on file at MID.
Mitral Valve Replacement
Currently, approximately 80,000 patients undergo valve repair or valve replacement surgery each year. The majority of the over four million mitral regurgitation (MR) sufferers do not receive treatment primarily due to the risks associated with cardiopulmonary bypass and open-heart surgery. While there are a variety of minimally invasive mitral valve repair techniques either under development or in clinical use, these techniques do not offer the same benefits in terms of elimination of MR as does surgical mitral valve replacement.
The Emergence of TMVR
New techniques and procedures are being developed for minimally invasive, catheter-based solutions for mitral valve repair and replacement. While there are no commercially approved devices available, MID is at the forefront with new technologies in development.
MID is developing a percutaneous approach to mitral valve replacement that leverages the acquired intellectual property of Endovalve™ and the PolyCor anchoring technology of Permaseal.