Abbott wins duo of FDA clearances for CentriMag life support system

Abbott (NYSE: ABT) +  announced today that it received two FDA clearances for its CentriMag system for life support.

The agency cleared the CentriMag blood pump for longer-term use in adults using the CentriMag system. These adults require extracorporeal membrane oxygenation (ECMO) to save their life. Longer-term support provides physicians more time to assess the next steps and make critical care decisions for patients.

Additionally, Abbott won FDA clearance for the new CentriMag pre-connected pack. This packaged system offers several pre-connected components of the CentriMag system. The company said in a news release that it accelerates the deployment of the life support system.

Combined, the clearances build out Abbott’s ability to offer leading life support systems, the company said.

About the new Abbott CentriMag clearances

The previous indication for the CentriMag pump covered providing life support for up to six hours. Abbott says this is often referred to as “short-term support.” It limited the flexibility for doctors to make care decisions, the company explains. Prolonged life support through ECMO enables Abbott’s CentriMag pump to temporarily replace the function of the heart. It can help patients with conditions like COVID-19 as well as those who underwent open heart surgery and require further ECMO support.

Abbott’s pre-connected pack aids in urgent cardiopulmonary support lasting less than six hours. It combines several system components, including the blood pump and oxygenator. The pack enables physicians to provide full support in fewer steps in critical care settings. Before clearance, the system required assembly from separate components. Abbott said this 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 Dr. Robert L. Kormos, M.D., divisional VP, 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.”