News | Coronavirus (COVID-19) | April 23, 2020

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

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

LivaNova Modifies its ECMO Indications Beyond Six Hours to Address COVID-19. The FDA expanded the use indications for ECMO systems April 6 so tthey can be used beyond six hours and for use in COVID-19 patients in need of circulatory and pulmonary support.

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

 

Related ECMO Use in COVID-19 Content:

FDA Approves ECMO to Treat COVID-19 Patients

New York City Physicians Note Multiple Cardiovascular Presentations of COVID-19

VIDEO: Multiple Cardiovascular Presentations of COVID-19 in New York — Interview with Justin Fried, M.D.


Related Content

News | Coronavirus (COVID-19)

March 20, 2024 — SARS-CoV-2, the virus that causes COVID-19, can damage the heart even without directly infecting the ...

Home March 20, 2024
Home
News | Coronavirus (COVID-19)

January 25, 2024 — New research confirms what public health leaders have been fearing: the significant uptick in the ...

Home January 25, 2024
Home
News | Coronavirus (COVID-19)

January 11, 2024 — Acute cardiovascular manifestations of COVID-19, such as heart failure, thrombosis, and dysrhythmia ...

Home January 11, 2024
Home
News | Coronavirus (COVID-19)

December 14, 2023 — Individuals infected with COVID-19 are also at an increased risk of suffering from heart rhythm ...

Home December 14, 2023
Home
News | Coronavirus (COVID-19)

October 16, 2023 — A door-to-balloon (D2B) time of 90-minutes or less is associated with improved outcomes for heart ...

Home October 16, 2023
Home
News | Coronavirus (COVID-19)

October 11, 2023 — Unvaccinated people who have recovered from COVID-19 are at heightened risk of heart complications ...

Home October 11, 2023
Home
News | Coronavirus (COVID-19)

September 26, 2023 — New research from the Smidt Heart Institute at Cedars-Sinai shows that patients who went to a ...

Home September 26, 2023
Home
News | Coronavirus (COVID-19)

June 19, 2023 — Patients who had heart attacks during the first COVID-19 lockdown in the UK and Spain are predicted to ...

Home June 19, 2023
Home
News | Coronavirus (COVID-19)

June 14, 2023 — A University of Waterloo engineer’s MRI invention reveals better than many existing imaging technologies ...

Home June 14, 2023
Home
News | Coronavirus (COVID-19)

June 9, 2023 — Patients infected with beta and delta COVID-19 variants, and those who required hospital stays for COVID ...

Home June 09, 2023
Home
Subscribe Now