LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring

LivaNova (NSDQ:LIVN) said today it won FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring, and said that the device has been used in its first commercial procedure.

The Memo 4D mitral annuloplasty ring is a next-generation device designed for treating patients with mitral regurgitation, and is available in sizes from 24 mm to 42 mm, the London-based company said.

“Memo 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets. 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 optimize mitral repair procedures rather than replacing the entire mitral valve,” Dr. Sreekumar Subramanian of Nashville’s TriStar Centennial Medical Center, who performed the first Memo 4D implant, said in a prepared statement.

The newly cleared device also features the company’s ReChord chordal guide intended to improve procedure times, a new ring design with dimensions better suited to treat enlarged annuli and reduce the risk of systolic anterior motion, LivaNova said.

The system also features semi-rigid stability and flexibility and a gradual saddle shape to optimize physiological geometry in an enlarged annuli.

“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,” LivaNova NA prez Jason Richey said in a press release.

Earlier this month, LivaNova said it won approval from Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve designed to treat aortic valve disease.

The post LivaNova wins FDA nod for Memo 4D mitral annuloplasty ring appeared first on MassDevice.

from MassDevice https://ift.tt/2lb5RDR