LivaNova Receives FDA Clearance and Completes First Implant for its MEMO 4D Semi-rigid Mitral Annuloplasty Ring

LONDON–(BUSINESS WIRE)–$LIVN–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 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.”

1 Measures correspond to intercommissural distance.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five
decades of experience and a relentless commitment to improve the lives
of patients around the world. LivaNova’s advanced technologies and
breakthrough treatments provide meaningful solutions for the benefit of
patients, healthcare professionals and healthcare systems. Headquartered
in London, LivaNova has a presence in more than 100 countries worldwide.
The Company currently employs more than 3,500 employees.
LivaNova operates as two businesses: Cardiac Surgery and
Neuromodulation, with operating headquarters in Mirandola (Italy)
and Houston (U.S.A.), respectively.

For more information, please visit www.livanova.com.

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Contacts

LivaNova PLC Investor Relations and Media
Karen King, +1
281-228-7262
Vice President, Investor Relations & Corporate
Communications
or
Deanna Wilke, +1 281-727-2764
Director,
Corporate Communications – Products & Therapies
corporate.communications@livanova.com