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HomeLivaNova PLCLivaNova Receives FDA Clearance and Completes First Implant for its

LivaNova Receives FDA Clearance and Completes First Implant for its

June 14, 2018

LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today 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 the market to offer the 42mm size1. Larger size rings facilitate repair in the presence of severe degenerative MR like Barlow’s disease or enlarged annuli.

“LivaNova is committed to innovation for mitral valve repair and replacement technology,” said Jason Richey, LivaNova’s President of North America. “Garnering FDA clearance for MEMO 4D addresses a real need and allows a broader patient population suffering from MR to be treated.”

Additional features of MEMO 4D include:

  • ReChord chordal guide system accelerates procedure times, while providing a standardized approach to neochordae implantation.
  • New ring design offers improved dimensions to treat enlarged annuli and reduce the risk of Systolic Anterior Motion (“SAM”).
  • True semi-rigid stability and flexibility to ensure a natural behavior.
  • Gradual saddle shape optimizes the physiological geometry in enlarged annuli.

The first MEMO 4D implant was performed by Dr. Sreekumar Subramanian M.D., FACS of TriStar Cardiovascular Surgery at TriStar Centennial Medical Center in Nashville, Tennessee.

“MEMO 4D simplifies and standardizes degenerative complex mitral valve repair, facilitates minimally invasive surgical approaches and preserves the mobility of the mitral valve leaflets,” said Subramanian. “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.”


Reference

1 Measures correspond to intercommissural distance.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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