LivaNova has announced that several of its cardiopulmonary products are can now be used in the USA for extracorporeal membrane oxygenation (ECMO) therapy for more than six hours, per guidance issued by the US Food and Drug Administration (FDA) on 6 April, 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 US 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
Damien McDonald, CEO of LivaNova, comments: “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.”
