(RTTNews) - Abiomed Inc. (ABMD) said Monday that the United States Food and Drug Administration has approved the Abiomed Breethe OXY-1 System, an all-in-one compact cardiopulmonary bypass system.
The company 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.
Abiomed said that its Breethe technology is a 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 ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The approval 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.
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