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MiCardia Announces First Dynamic Adjustment Of The Mitral Valve Annular Geometry On A Beating Heart In DYANA Study

MiCardia Corporation has announced the first dynamic heart valve repair on a beating heart. This marks the first dynamic adjustment of the MiCardia’s novel Dynaplasty mitral valve repair technology in the European Dynamic Annuloplasty Activation (DYANA) Study. The study is designed to provide data for CE Mark of the company’s groundbreaking Dynaplasty Technology. MiCardia expects to complete enrollment and submit six month follow up data from the DYANA Study in 2009 as a prelude to European commercialization of the world’s first dynamically activated mitral valve repair system. MiCardia’s Dynaplasty System has received a 510(k) clearance on its static version in September 2008 and implants will commence shortly at several prestigious centers in the US. The company intends to submit US implant data as part of its European CE Mark submission and in turn capture critical clinical data from its European DYANA Study to support regulatory submissions and commercialization of its systems in the US subsequently.