FDA Clears Abbott's Blood Pump for Longer-Term Use

The company also received FDA clearance for its CentriMag Pre-connected Pack for urgent cardiopulmonary support lasting less than six hours.

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Abbott today announced two new clearances from the U.S. Food and Drug Administration (FDA) for the company's life support system. With the new indication, the CentriMag Blood Pump for use with the CentriMag System, is now cleared for longer-term use in adults when extracorporeal membrane oxygenation (ECMO) – a type of life support for people whose heart and lungs are not working – is critical to saving their life. Now, the clearance for longer-term support allows physicians more time to assess next steps and make critical care decisions for their patients.

Abbott also received FDA clearance for its new CentriMag Pre-connected Pack β€“ 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.

The CentriMag pump was previously cleared for providing life support for up to six hours – often referred to as "short-term support" – which limited the flexibility for doctors to make care decisions for patients battling critical conditions or for those whose heart can't pump enough blood to meet their body's needs. By providing prolonged life support for more than six hours through ECMO – which physicians often call "long-term support" – Abbott's CentriMag pump temporarily replaces the function of the heart.

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. 

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.

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."

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