UK-based medical technology company LivaNova has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its MEMO 4D semi-rigid mitral annuloplasty ring.
The new device expands the company’s MEMO range and is available in sizes varying from 24mm to 42mm. They are designed to provide more options for patients suffering from mitral regurgitation (MR).
Memo 4D’s large-size rings enable repair even in the case of severe degenerative MR such as Barlow’s disease or enlarged annuli. The improved dimensions are also expected to minimise the risk of systolic anterior motion (SAM).
The MEMO 4D device also features ReChord chordal guide system that expedites procedure time and offers a standardised method for implanting neochordae.
In addition, the semi-rigid stability and flexibility of the ring will facilitate natural behaviour, while its gradual saddle design streamlines the physiological geometry in enlarged annuli.
LivaNova North America president Jason Richey said: “LivaNova is committed to innovation for mitral valve repair and replacement technology.
“Garnering FDA clearance for MEMO 4D addresses a real need and allows a broader patient population suffering from MR to be treated.”
The first implantation of the device has been performed at US-based TriStar Centennial Medical Center by Sreekumar Subramanian, who said that the semi-rigid mitral annuloplasty ring simplifies repair of the degenerative mitral valve, allowing for minimally invasive surgery.
Subramanian further added: “The new larger sizes allow us to treat more patients and pathologies while providing the potential to further improve patient outcomes. With MEMO 4D, surgeons can optimise mitral repair procedures rather than replacing the entire mitral valve.”