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Abbott also received FDA clearance for its new CentriMag Pre-connected Pack – a packaged system with several pre-connected components of the CentriMag system that can accelerate the deployment of the life support system. Combined, the dual clearances further build out Abbott's ability to offer leading life support systems to hospitals and physicians managing critically ill patients.
New Indication Provides More Time on Life Support
The life support system pumps blood outside of the body and into a series of devices that add oxygen, where a machine then pumps the oxygenated blood back into the body [i] . Used in intensive care units, the support became a life-saving resource for many people during the COVID-19 pandemic.
"Life support technology is a critical tool for physicians as we assess next steps for our sickest patients. The need for long-term support from systems like the Abbott CentriMag pump was vital during the COVID-19 pandemic," said Antone Tatooles , M.D., a cardiothoracic surgeon at Advocate Christ Hospital and Medical Center in Oak Lawn, Ill.
Aside from treating patients with conditions such as COVID-19, the new longer-term indication for Abbott's CentriMag pump also provides physicians with more options for treating patients who have undergone open heart surgery and require further ECMO support.
Second FDA Clearance Strives to Give Physicians More Time
In addition to a longer-term indication for the CentriMag pump for use with the CentriMag system, Abbott also received FDA clearance for its CentriMag Pre-connected Pack for urgent cardiopulmonary support lasting less than six hours. The Pre-connected Pack combines several system components including the blood pump and oxygenator, allowing physicians to provide full support in fewer steps in the most urgent of critical care settings. Previous to this clearance, the system needed to be put together from separate components, which could lead to delays in urgent care.
"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," said Robert L. Kormos , M.D., divisional vice president, global medical affairs, Abbott's heart failure business. "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."
Indications and Important Safety Information:
For U.S. important safety information for the CentriMag System and Pre-connected Pack, visit: Indications, Safety and Warnings for the CentriMag System | Abbott (cardiovascular.abbott)
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[i] Cleveland Clinic. ECMO. What Is ECMO? (clevelandclinic.org) . Accessed April 7, 2023 .