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

“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

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

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

Safe Harbor Statement

This news release contains forward-looking statements within the meaning
of Section 27A of the United States Securities Act of 1933, as amended,
and Section 21E of the United States Securities Exchange Act of 1934, as
amended. Forward-looking statements are not historical facts but are
based on certain assumptions of management and describe LivaNova’s
future plans, strategies and expectations. Forward-looking statements
can generally be identified by the use of forward-looking terminology,
including, but not limited to, “may,” “could,” “seek,” “guidance,”
“predict,” “potential,” “likely,” “believe,” “will,” “expect,”
“anticipate,” “estimate,” “plan,” “intend,” “forecast,” or variations of
these terms and similar expressions, or the negative of these terms or
similar expressions. Forward-looking statements contained in this news
release are based on information presently available to LivaNova and
assumptions that LivaNova believes to be reasonable, but are inherently
uncertain. As a result, LivaNova’s actual results, performance or
achievements may differ materially from those expressed or implied by
these forward-looking statements, which are not guarantees of future
performance or actions that may be taken by LivaNova and involve known
and unknown risks, uncertainties and other factors that are, in some
cases, beyond LivaNova’s control. You should carefully consider the
risks and uncertainties that affect LivaNova, including those described
in the “Risk Factors” section of LivaNova’s Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other
documents filed from time to time with the United States Securities and
Exchange Commission.

All information in this news release is as of the date of its release.
LivaNova does not undertake or assume any obligation to update publicly
any of the forward-looking statements in this news release to reflect
actual results, new information or future events, changes in assumptions
or changes in other factors affecting forward-looking statements, except
to the extent required by applicable law. If we update one or more
forward-looking statements, no inference should be drawn that we will
make additional updates with respect to those or other forward-looking
statements. We caution you not to place undue reliance on any
forward-looking statements, which are made only as of the date of this
news release.


LivaNova PLC Investor Relations and Media
Karen King, +1
Vice President, Investor Relations & Corporate
Deanna Wilke, +1 281-727-2764
Corporate Communications – Products & Therapies