The Mitralign percutaneous annuloplasty system (MPAS) has received CE mark approval from the British Standards Institution for the treatment of functional mitral regurgitation (FMR). The product can now be marketed within the European Union.
The CE mark study tested the Mitralign’s ability to meet both its 30-day safety and six-month performance targets. Patients treated with the Mitralign system in the prospective, multi-centre, single-arm study showed statistically significant (p<0.05) improvements in a six-minute walk test, left ventricular dimensions and remodelling.
“The data show treatment with the Mitralign System is safe in FMR patients.” says 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.”
Mitralign provides 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 customisable 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 investigational device exemption study in the USA, and is not approved for sale or distribution.