CE Mark for Mitralign Percutaneous Annuloplasty System to treat mitral and tricuspid regurgitation- Mitralign Inc.

Mitralign, Inc., an innovative developer of direct transcatheter mitral and tricuspid valve repair solutions, announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its notified body, the British Standards Institution (BSI), for the treatment of functional mitral regurgitation (FMR). This confirmation offers a unique new treatment alternative for patients with symptomatic functional mitral valve regurgitation. CE mark approval allows the company to market the Mitralign System in the European Union.

Data from the CE mark study demonstrated the Mitralign System met both its 30 day safety and its six month performance endpoints. In the prospective, multi-center, single arm study, patients treated with the Mitralign System demonstrated statistically significant (p<0.05) improvements in 6 minute walk test, left ventricular dimensions and remodeling; reversing the course of heart dilation due to heart failure.

Comment; Mitralign is the only company to provide a direct transcatheter annuloplasty system designed to treat both functional mitral regurgitation (FMR) and tricuspid regurgitation (TR). Both the Mitralign and Trialign Systems feature a customizable therapy solution in concert with an extremely small footprint that leaves all clinical options open for the physician. MPAS is not available for sale in the USA. The Trialign System is currently enrolling patients in an early feasibility IDE study in the USA .