LivaNova Modifies its ECMO Indications Beyond Six Hours to Address COVID-19

The FDA expanded the use indications for ECMO systems April 6 so the systems can be used beyond six hours and for use in COVID-19 patients in need of circulatory and pulmonary support. Image shows an ECMO team at work at Tufts Medical Center in Boston in December 2019. Photo by Dave Fornell

April 23, 2020 – LivaNova PLC said the U.S. Food and Drug Administration (FDA) is now permitting the company to expand its indicated use of extracorporeal membrane oxygenation (ECMO) therapy for longer than six hours. This is allowed under FDA guidance issued April 6 to temporarily expand the availability of devices to address the novel coronavirus (COVID-19, SARS-CoV-2) 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: www.livanova.com/coronavirus