FDA approves Memo 4D mitral annuloplasty ring for treatment of mitral regurgitation.- LivaNova.
LivaNova PLC a market-leading medical technology company, announced it received FDA 510(k) clearance for its MEMO 4D semi-rigid mitral annuloplasty ring and confirmed the first implantation of the device.
MEMO 4D, LivaNova’s next-generation of the MEMO device family, now offers a broader range of ring sizes from 24 to 42mm allowing an additional patient population with mitral regurgitation (“MR”) to be treated. MEMO 4D is the only annuloplasty ring on market to offer the 42mm size. Larger size rings facilitate repair in the presence of severe degenerative MR like Barlow’s disease or enlarged annuli.
Comment: The device provides a chordal guide to speed up procedure times, and its improved ring design can reduce the risk of systolic anterior motion.
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