LONDON--(BUSINESS WIRE)--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.
For more information, visit www.livanova.com/coronavirus.
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.
For more information, visit www.livanova.com.
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