Mitralign's MPAS Approved in Europe to Treat Functional Mitral Regurgitation

February 22, 2016—Mitralign, Inc. announced that the Mitralign percutaneous annuloplasty system (MPAS) has received European CE Mark approval for the treatment of functional mitral regurgitation (FMR). The approval allows the company to market the MPAS as a new treatment alternative for patients with symptomatic FMR in the European Union. The MPAS is not available for sale in the United States, advised the company.

According Mitralign, data from the CE Mark study demonstrated that MPAS met both its 30-day safety and its 6-month performance endpoints. In the prospective, multicenter, single-arm study, patients treated with the Mitralign system demonstrated statistically significant (P < .05) improvements in 6-minute walk test, left ventricular dimensions, and remodeling, thereby reversing the course of heart dilation caused by heart failure.

In Mitralign’s press release, Prof. Georg Nickenig, MD, commented, “The data show treatment with the Mitralign system is safe in FMR patients. Due to its versatility and small footprint, the device can be considered a front-line treatment option for patients with mitral regurgitation.” Prof. Nickenig is with the University of Bonn in Germany.

The company offers direct transcatheter annuloplasty systems designed to treat both FMR and tricuspid regurgitation and continues to study its Trialign system for tricuspid repair. The Trialign system is currently enrolling patients in an early feasibility investigational device exemption study in the United States and is not approved for sale or distribution. 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, stated the company.