New US FDA certifications for Abbott’s life support system will enable medical professionals to treat more seriously ill patients.

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The US Food and Drug Administration (FDA) recently granted Abbott two more clearances for the company’s market-leading life support system. The CentriMag Blood Pump for use with the CentriMag System is now approved for longer-term usage in adults where extracorporeal membrane oxygenation (ECMO), a kind of life support for persons whose heart and lungs are not functional, is necessary to save their lives. The approval for longer-term support now gives doctors more time to consider their patients’ needs and determine the best course of action. The CentriMag Pre-connected Pack, a packaged system containing multiple pre-connected CentriMag system components that can speed up the deployment of the life support system, was also given FDA approval by Abbott. When combined, the two clearances strengthen Abbott’s capacity to provide hospitals and doctors with cutting-edge life support systems for critically ill patients.

Prior to its approval, the CentriMag pump could only provide “short-term support” (also known as life support for up to six hours), which gave doctors little leeway in deciding how to treat patients with life-threatening conditions or those whose hearts couldn’t pump enough blood to meet their bodies’ requirements. Abbott’s CentriMag pump temporarily replaces the function of the heart by prolonging life support for more than six hours with ECMO, also known as “long-term support” among medical professionals. A machine then pumps the oxygenated blood back into the body as part of the life support system, which pumps blood outside the body and into a series of oxygen-adding devices. During the Covid-19 outbreak, the assistance, which was used in intensive care units, helped many individuals stay alive.

“Life support technology is a crucial tool for doctors as they determine the best course of action for their sickest patients. During the Covid-19 pandemic, long-term assistance from devices like the Abbott CentriMag pump was essential, according to Dr. Antone Tatooles, a cardiothoracic surgeon at Advocate Christ Hospital and Medical Centre in Oak Lawn, Illinois. The new longer-term indication for Abbott’s CentriMag pump gives doctors more alternatives for treating patients who have had open heart surgery and need additional ECMO support in addition to treating those with disorders like Covid-19.

Abbott gained FDA approval for its CentriMag Pre-connected Pack for immediate cardiopulmonary support lasting less than six hours in addition to a longer-term indication for use with the CentriMag system. In the most urgent of critical care conditions, the Pre-connected Pack integrates a number of system parts, such as the blood pump and oxygenator, and enables doctors to offer full support in fewer steps. Prior to its approval, the system had to be assembled from individual parts, which can cause delays for urgent care.

According to Robert L. Kormos, M.D., divisional vice president, global medical affairs, Abbott’s heart failure business, “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 approvals, doctors may deploy support in fewer steps and have more time to get their patients the treatment they need during a crucial window.

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