Abbott announces two FDA clearances for life support system
pharmafile | April 26, 2023 | News story | Medical Communications |
US-based medical devices and healthcare company Abbott has announced two new clearances from the US Food and Drug Administration (FDA) for its life support system.
The CentriMag Blood Pump, for use with the CentriMag System, is now cleared for longer-term use in adults when extracorporeal membrane oxygenation (ECMO) is critical to saving their life ‒ ECMO is a type of life support which replaces heart and lung function when these have failed. This gives physicians more time to assess next steps and make critical care decisions for their patients.
The CentriMag pump was initially indicated for use in ‘short-term life support’, meaning support for up to six hours, however this limited the actions doctors could take for patients battling critical conditions.
Abbott also received clearance for its new CentriMag Pre-connected Pack, a packaged system with several pre-connected components of the CentriMag system which can accelerate the deployment of the life support system.
Robert L Kormos MD, divisional vice president, global medical affairs, Abbott’s heart failure business, commented: “With CentriMag, our mission has always been to transform the treatment of advanced cardiac and respiratory conditions to improve clinicians’ ability to most effectively manage their sickest patients. With the two new FDA clearances, physicians can deploy support in fewer steps and are provided more time to get their patients the necessary treatment during a critical window.”