Release Details

LivaNova Permitted to Modify Cardiopulmonary Products' Indications for Use to Include ECMO Therapy Beyond Six Hours to Address COVID-19

April 22, 2020

Various products can now be used to treat patients experiencing acute respiratory or cardiopulmonary failure

LONDON--(BUSINESS WIRE)--Apr. 22, 2020-- LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced that several of its cardiopulmonary products are now permitted to be used in the U.S. for Extracorporeal Membrane Oxygenation (ECMO) therapy greater than six hours per guidance issued by the U.S. Food and Drug Administration (FDA) on April 6 to temporarily expand the availability of devices to address the coronavirus (COVID-19) pandemic.

This guidance is intended to remain in effect during the COVID-19 public health emergency declared by the U.S. Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary. Product indications for use have been modified accordingly for the following LivaNova products and product lines:

  • S5® heart-lung machine
  • CP5® centrifugal pump driver
  • Revolution® centrifugal pump
  • Inspire® family of oxygenators
  • EOS® PMP oxygenator
  • LifeSPARC™ pump and controller
  • TandemHeart® pump and controller
  • TandemLung® oxygenator
  • ProtekDuo® cannula

“During this critical time, LivaNova is committed to helping patients impacted by the COVID-19 pandemic in every way we can,” said Damien McDonald, Chief Executive Officer of LivaNova. “We are pleased to offer cardiopulmonary and advanced circulatory support products and therapies that may benefit patients in need and will continue to work with health authorities to help fight this pandemic.”

During ECMO procedures, a patient’s blood is externally oxygenated and recirculated through the body to provide circulatory and respiratory support. To expand availability of such therapy, the FDA is permitting manufacturers of cardiopulmonary bypass devices to modify the product indications for use to include ECMO therapy greater than six hours, without prior submission of a premarket notification to FDA. The listed LivaNova products are being made available to support ECMO therapy for greater than six hours and now have updated labeling with a Special Supplement to the Product Package, including recommendations and use conditions to help users understand the products’ use in ECMO therapy. Users of these products should carefully review the Instructions for Use and the Special Supplement to the Product Package.

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About LivaNova

LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 4,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.

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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 Media Contact
Deanna Wilke, +1 (281) 727-2764
VP, Corporate Communications

Source: LivaNova