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www.fdanews.com/articles/175432-mitralign-secures-ce-mark-for-percutaneous-annuloplasty-system

Mitralign Secures CE Mark for Percutaneous Annuloplasty System

February 22, 2016

Mitralign has received CE Mark approval from BSI for it Mitralign percutaneous annuloplasty system for treatment of symptomatic functional mitral regurgitation.

“The CE Mark for FMR is the first approved indication for the Mitralign platform,” Rick Geoffrion, CEO of Mitralign, said in a prepared statement. He added that the CE Mark will bolster efforts to encourage the study the company’s platform, including the Trialign system for tricuspid repair.

Mitralign is currently the only company to offer a direct transcatheter annuloplasty system intended to treat both FMR and tricuspid regurgitation, according to the statement. — Anisa Jibrell