LivaNova (NSDQ:LIVN) announced that some of its cardiopulmonary products are now permitted for extended use in specific therapies after the FDA expanded device availability amid the COVID-19 pandemic.
On April 6, the FDA issued guidance to temporarily expand the availability of certain devices in an effort to address the coronavirus crisis. Along the guidelines given by the agency, LivaNova’s cardiopulmonary products are now available for use in extracorporeal membrane oxygenation (ECMO) therapy greater than six hours.
A patient’s blood is externally oxygenated and recirculated for circulatory and respiratory support during ECMO procedures, and the FDA is now permitting manufacturers of applicable devices to modify their indications to include ECMO therapy greater than six hours.
The FDA guidance is intended to remain in effect during the public health emergency declared by the U.S., and in this case it applies to LivaNova’s:
- 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,” LivaNova CEO Damien McDonald said in a news release. “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.”