Abiomed has announced that its compact Abiomed Breethe OXY-1 cardiopulmonary bypass system has treated its first two patients in the world.
The advanced ECMO technology can pump, oxygenate and eliminate carbon dioxide from the blood for patients whose lungs fail to offer sufficient end-organ oxygenation.
It can aid in providing oxygenation to patients suffering from cardiogenic shock or respiratory failure from ARDS, H1N1, SARS or Covid-19.
With an integrated oxygen concentrator, the easy-to-use system can provide an independent oxygen source for offering mobility.
The Abiomed Breethe OXY-1 System can unload the heart and oxygenate the body, a combination therapy called ECpella, when it is used with the Impella heart pump.
The first patient, a 21-year-old woman, at the University of Maryland Medical Center sustained a lung injury and was placed on V-V ECMO with Breethe system.
Abiomed noted that the patient’s condition improved rapidly and was able to ambulate daily. She was successfully taken off Breethe support after eight days and is out of the ICU.
Another patient treated for respiratory failure due to Covid-19 became stable and improved after 24 hours.
HUMC/Hackensack Meridian Health Heart and Vascular Hospital cardiac surgery division chief and cardiothoracic surgeon Mark Anderson said: “Breethe is an important new option for patients with Covid-19 who require ECMO therapy.
“It is simple and intuitive to use, highly portable and a very promising therapy with the potential to help many patients.”
In October, the US Food and Drug Administration (FDA) granted a 510(k) clearance for the Abiomed Breethe OXY-1 System to provide extracorporeal circulation.
In June, Abiomed received Emergency Use Authorisation (EUA) from the FDA for the use of its Impella RP temporary heart pump in patients suffering from right-side heart failure or decompensation related to Covid-19.