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# Abiomed’s Cardiopulmonary Bypass Cleared by FDA
- URL: https://www.fdaweb.com/abiomeds-cardiopulmonary-bypass-cleared-by-fda/
- Published: 2020-10-27T12:00:00.000Z
- Updated: 2026-09-14T16:34:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147966

FDA has granted Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the [Abiomed Breethe OXY-1 System](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.abiomed.com%2Fbreethe&esheet=52313462&newsitemid=20201026005299&lan=en-US&anchor=Abiomed+Breethe+OXY-1+System%26%238482%3B&index=2&md5=57e8f228561a64b8809c148eb76be512&ref=fdaweb.com). The device provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. It is intended to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass for up to six hours. The system can help provide oxygenation to patients suffering from cardiogenic shock or respiratory failure caused by viruses like Covid-19\. When used with the Impella heart pump it can unload the heart and oxygenate the body, a combination therapy known as ECpella, the company says. “The integrated pump lung unit is engineered with volute spiral technology for uniform blood flow with minimal stagnation and advanced gas exchange technology that allows for full therapy with reduced oxygen requirements,” it adds.