April 27, 2016 — Mitralign Inc. 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.
“The data show treatment with the Mitralign System is safe in FMR patients,” said Prof. Georg Nickenig of the University of Bonn. “Due to its versatility and small footprint, the device can be considered a front-line treatment option for patients with mitral regurgitation.”
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.
Mitralign is the only company to provide a direct transcatheter annuloplasty system designed to treat both 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 United States. The Trialign System is currently enrolling patients in an early feasibility investigational device exemption (IDE) study in the U.S. and is not approved for sale or distribution.
For more information: www.mitralign.com