UK-based medical technology firm LivaNova has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Memo 4D semi-rigid mitral annuloplasty ring.
Image: LivaNova’s Memo 4D semi-rigid mitral annuloplasty ring. Photo: courtesy of Business Wire.
Part of the Memo device family, the next-generation Memo 4D is available in ring sizes ranging from 24mm to 42mm, helping to treat additional patient population with mitral regurgitation (MR).
LivaNova has also reported the first implantation of the Memo 4D semi-rigid mitral annuloplasty ring.
The Memo 4D, which is claimed to be the only annuloplasty ring on market to offer the 42mm size, facilitated repair in the presence of severe degenerative MR such as Barlow’s disease or enlarged annuli.
The Memo 4D is provided with ReChord chordal guide system to accelerate procedure times.
It also features new ring design that provides improved dimensions to treat enlarged annuli and reduce the risk of systolic anterior motion.
In addition, the Memo 4D’s gradual saddle shape is said to optimize 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.”
In October 2017, LivaNova secured FDA approval for its new stented aortic bioprosthesis Crown phospholipid reduction treatment (PRT) for aortic valve disease.
Featuring advanced stented aortic bioprosthesis technology, Crown PRT is a suitable aortic valve replacement option for older patients.
Crown PRT enables intraoperative handling through enhanced ease of implant with visible markers and improved radiographic visualization through dedicated X-ray markers.
Based in London, LivaNova carries out operations in more than 100 countries across the globe.
With over 3,500 employees, the company operates two businesses, including cardiac surgery and neuromodulation.