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Home » FDA clears Abiomed compact cardiopulmonary bypass system

FDA clears Abiomed compact cardiopulmonary bypass system

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Abiomed Breethe OXY-1 System
The Breethe OXY-1 system [Image courtesy of Abiomed]
Abiomed (NSDQ:ABMD) announced today that FDA has granted a 510(k) clearance for its Breethe OXY-1 system — which among other things could help treat people with severe cases of COVID-19.

The Abiomed Breethe OXY-1 system is an all-in-one, compact cardiopulmonary bypass system. It provides cardiopulmonary bypass support for people whose lungs are no longer able to supply significant oxygen to their bodies’ organs.

The clearance allows the use of the Breethe OXY-1 to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass for up to six hours.

When used with Abiomed’s Impella heart pump, the Breethe OXY-1 can unload the heart and oxygenate the body, a combination therapy known as ECpella. Think life-sustaining support for people suffering from cardiogenic shock or respiratory failure due to ARDS, H1N1, SARS or COVID-19.

“This ECMO technology will allow us to support new patient populations, such as COVID-19 patients and others who need lung support, and provide combination ECpella therapy to Impella patients who need oxygenation. Furthermore, we will advance the field of native lung recovery and improve patient outcomes by collecting critical research data and developing and teaching best practices,” Abiomed CEO Michael R. Minogue said in a news release.

 

 

 

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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