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The US Food and Drug Administration (FDA) has permitted LivaNova to modify several of its cardiopulmonary products for extended use in Extracorporeal Membrane Oxygenation (ECMO) therapy longer than six hours to address Covid-19.
The move is intended to temporarily expand the availability of devices for the pandemic.
A patient’s blood is externally oxygenated and recirculated for circulatory and respiratory support during ECMO procedures. To expand the availability of such therapies, the agency is now allowing manufacturers of applicable devices to modify their indications without prior submission of premarket notification.
Currently, LivaNova products are being made available to support ECMO therapy for longer than six hours. They include S5 heart-lung machine, CP5 centrifugal pump driver, Revolution centrifugal pump, inspire family of oxygenators, EOS PMP oxygenator, LifeSPARC pump and controller.
Other LivaNova products are TandemHeart pump and controller, TandemLung oxygenator and ProtekDuo cannula.
These products can now be used to treat patients experiencing acute respiratory or cardiopulmonary failure associated with the Covid-19 disease.
LivaNova CEO Damien McDonald said: “During this critical time, LivaNova is committed to helping patients impacted by the Covid-19 pandemic in every way we can.
“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.”
The new FDA guidance is expected to stay in effect during the Covid-19 public health emergency declared by the US Department of Health and Human Services (HHS). It is also subject to any renewals made by the HHS Secretary.