US-based medical devices and health care firm Abbott has secured two new clearances from the US Food and Drug Administration (FDA) for its CentriMag life support system.
The FDA has cleared the CentriMag Blood Pump for longer-term use with the CentriMag System to provide extracorporeal membrane oxygenation (ECMO) to save patients’ lives. It is useful for adults whose hearts and lungs are not working.
Abbott said that the clearance will provide more time for physicians to evaluate the next steps and take critical care decisions for patients.
Additionally, the medical device company secured FDA approval for its new CentriMag Pre-connected Pack.
The packaged system, which comes with several pre-connected parts of the CentriMag system, is intended to expedite the deployment of the life support system.
When combined, both clearances will support Abbott to offer life support systems to hospitals and doctors who manage critically ill individuals.
Abbott heart failure business global medical affairs divisional vice president Robert Kormos said: “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.”
Previously, the CentriMag pump was approved to offer short-term support for up to six hours to patients who require life support.
The medical device company said that the pump however limited the flexibility for surgeons to make better care decisions.
The prolonged life support via ECMO will enable the CentriMag pump to replace the heart’s function temporarily, Abbott added.
The new longer-term indication is said to be useful for conditions like Covid-19 and for patients who underwent open heart surgery and need further ECMO support.
According to the company, the Pre-connected Pack helps in urgent cardiopulmonary support lasting less than six hours. It combines components like the blood pump and oxygenator to provide full support in fewer steps in critical care settings.
Earlier, the CentriMag Pre-connected Pack needed to be assembled which led to delays in urgent care, Abbott said.
