Mitralign Percutaneous Annuloplasty System Earns CE Mark Approval for Functional Mitral Regurgitation
WASHINGTON &
TEWKSBURY, Mass., Mitralign, Inc., an
innovative developer of direct transcatheter mitral and tricuspid valve repair
solutions, today 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.
“The CE mark for FMR is the first approved indication for the Mitralign platform and it provides clear validation of the technology,” stated Rick Geoffrion, chief executive officer of Mitralign. “This key accomplishment lends momentum to our efforts with physicians and regulatory agencies to continue to study our platform, including the TrialignTM System for tricuspid repair.”
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 and is not approved for sale or distribution.
Source: Mitralign Inc.
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