Overview
The OXY-1 System is an easy-to-use, compact cardiopulmonary support system with an integrated oxygen concentrator that provides an independent oxygen source to help the patient move around during therapy. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood. It has a novel design that is intuitive for health care providers to set up, manage and monitor.
The OXY-1 System is designed with an advanced gas exchange technology, including an innovative oxygen concentrator that provides full patient support with reduced O2 demand.
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Abiomed Breethe OXY-1 System Device Indication & Safety Information
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.
The OXY-1 System must be operated and/or monitored by users with specialized training in extracorporeal circulation therapy. These users include perfusionists, extracorporeal circulation specialists, ICU nurses with specialized extracorporeal circulation training, cardiothoracic surgeons, intensivists, and others with specialized training and experience. Users are required to be knowledgeable and experienced in methods that require cardiopulmonary bypass and mechanical circulatory support.
Utilization of the Abiomed Breethe OXY-1 System requires clinical judgment for patient risks vs benefits in all circumstances and requires specialized training in the use of cardiopulmonary bypass systems for safe operation under the direct supervision of a qualified physician. This is a prescription-only device.
Contraindications
This device used for any other purposes than for the indicated intended use is the responsibility of the user.
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with the Abiomed Breethe OXY-1 System.
TEMPORARY ECMO INDICATION MODIFICATION DURING COVID-19 EMERGENCY
Under guidance issued by FDA, on April 6, 2020, the Abiomed Breethe OXY-1 System is now permitted to be used temporarily in the U.S. for ECMO therapy greater than six hours. Therefore, it now has a limited indication modification for use longer than six hours in an extracorporeal membrane oxygenation (ECMO) circuit to treat patients who are experiencing acute temporary respiratory or acute cardiopulmonary failure. This limited indication modification for ECMO therapy greater than six hours has not been cleared or approved by FDA and is in effect only for the duration of the public health emergency related to COVID-19 as declared by the U.S. Department of Health and Human Services (HHS).
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