LiveNova wins FDA clearance for mitral annuloplasty ring


LivaNovaLivaNova recently announced that it has received FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring.

Memo 4D is the next generation of devices in the company’s Memo device family. It comes in a wide range of ring sizes from 24 to 42mm, allowing for more patients with mitral regurgitation to get treatment. Currently, the Memo 4D is the only annuloplasty ring on the market that offers the 42mm size. Larger rings are used for repair in cases of severe degenerative mitral regurgitation like in Barlow’s disease or with an enlarged annuli.

“LivaNova is committed to innovation for mitral valve repair and replacement technology,” said Jason Richey, LivaNova’s president of North America. “Garnering FDA clearance for MEMO 4D addresses a real need and allows a broader patient population suffering from MR to be treated.”

The Memo 4D device also has a ReChord chordal guide system that accelerates procedure times while giving a standardized approach to neochordae implantation. It offers a new ring design for improved dimensions to treat enlarged annuli while reducing the risk of Systolic Anterior Motion. The Memo 4D features semi-rigid stability and flexibility to ensure natural behavior and a gradual saddle shape to optimize the physiological geometry in enlarged annuli.

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