www.fdanews.com/articles/187223-livanova-announces-fda-clearance-of-mitral-annuloplasty-ring
LivaNova Announces FDA Clearance of Mitral Annuloplasty Ring
June 14, 2018
The FDA granted 510(k) clearance for LivaNova’s Memo 4D semi-rigid mitral annuloplasty ring and confirmed the device’s first implantation.
The Memo 4D now offers a broader range of ring sizes from 24 to 42mm, allowing a new patient population to be treated for mitral regurgitation.
The device provides a chordal guide to speed up procedure times, and its improved ring design can reduce the risk of systolic anterior motion.