Danvers, Mass.-based Abiomed’s extracorporeal membrane oxygenation (ECMO) technology pumps, oxygenates and removes carbon dioxide from blood for patients whose lungs can’t provide sufficient end-organ oxygenation, according to a news release.
Breethe OXY-1 is designed to help oxygenate patients suffering from cardiogenic shock or respiratory failure from ARDS, H1N1, SARS or COVID-19, the company said, while it can unload the heart and oxygenate the body in a combination called ECpella when used with Abiomed’s Impella heart pump.
Abiomed’s Breethe OXY-1 system received FDA 510(k) clearance in October and the company is rolling it out through a controlled launch at select U.S. hospitals, with full availability country-wide expected to come in 2021.
The first patient treated with Breethe was a 21-year-old woman at the University of Maryland Medical Center who sustained a lung injury and was placed on V-V ECMO with the Breethe system.
According to Abiomed, her condition immediately improved and she was able to ambulate daily. Then, after eight days, the patient was weened off Breethe and is no longer in the ICU. She was treated by the University of Maryland Medical Center’s Dr. Bartley Griffith and Dr. Daniel Herr.
The second patient, a 51-year-old woman at HUMC/Hackensack Meridian Health, was treated for respiratory failure due to COVID-19. After 24 hours of V-V ECMO support on Breethe, she is stable and improving. HUMC/Hackensack Meridian Health chief of cardiac surgery Dr. Mark Anderson treated the second patient.
“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,” Anderson said in the news release.
“This revolutionary technology will change the way we think about extracorporeal life support therapy by enabling physicians to easily mobilize their patients in turn promoting a faster recovery,” added Griffith. “I am pleased to be a part of this milestone as Abiomed continues to advance respiratory and cardiac support to improve patient outcomes.”