SPM

Mitral Technologies is dedicated to the development and marketing of a novel device to for the treatment of mitral valve regurgitation through mitral valve repair. 

2% of the world population suffers from mitral valve regurgitation mainly as a consequence of heart attack. 9.3% of people 75 years old or more have severe mitral regurgitation (MR).

Mitral Technologies device and procedure will allow physicians to treat mitral regurgitation through a transcatheter procedure commonly used by interventional cardiologists. Learning curve for this new technology is expected to be minimal because it is based on cardiologist’s standard expertise.

2 million people suffering from MR are not suitable for surgery due to high surgical risks. This population will definitely benefit of transcatheter mitral valve regurgitation repair.  The second group of patients involves the 50% of patients who are denied surgery because of poor left ventricular function that would not survive the one step MR correction because of poor heart function. . These patients will greatly benefit from a transcatheter treatment of MR that progressively reduces the regurgitation in several steps giving to the heart time to adapt (remodel) to a better mitral valve function.

The development of this project is anticipated to take 5 and 1/2 years until CE marking approval. This plan described the research and development, the pre-clinical and clinical testing and the regulatory steps needed to reach CE marking.