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

Jun 14, 2018

LONDON--(BUSINESS WIRE)--Jun. 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 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.

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LivaNova MEMO 4D semi-rigid mitral annuloplasty ring (Photo: Business Wire)

LivaNova MEMO 4D semi-rigid mitral annuloplasty ring (Photo: Business Wire)

“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.

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.

 

Source: LivaNova PLC

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