FDA grants 510(k) clearance for a cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System.-Abiomed

The FDA has granted Abiomed a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System. The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The 510(k) clearance is 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 such as ARDS, H1N1, SARS, or COVID-19. When used with the Impella heart pump it can unload the heart and oxygenate the body, a combination therapy known as ECpella. Abiomed’s Breethe technology is a novel, easy-to-use cardiopulmonary bypass system that is designed for mobility. The components of the system are designed to reduce the overall equipment footprint, support patient ambulation, and provide an intuitive interface for health care providers to setup and manage. 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. Abiomed plans to have a controlled launch of the Breethe system at hospitals in the United States, with full U.S. commercial availability expected in calendar year 2021.