Abiomed Breethe OXY-1 System™

Cardiopulmonary Support System

Overview

The OXY-1 System is the novel, easy-to-use, compact cardiopulmonary support system, with an integrated oxygen concentrator and pump that provides an independent oxygen source to support transition from bed to ambulation via system portability. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood.

  • Designed for Mobility: All-in-one compact design with built-in oxygen concentrator
  • Integrated Pump Lung Unit: Volute spiral technology designed for uniform blood flow to minimize stagnation and thrombosis
  • Advanced Gas Exchange Technology: Innovative gas path enables full therapy with minimal O2 demand
  • Easy and Intuitive: Simple for health care providers to set up, manage and monitor
  • Tailored Patient Strategy with Abiomed Support: 24/7 on-call and on-site support for Impella® and extracorporeal MCS

Oxygenator Performance

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.

Accessories

Additional Resources

Abiomed Breethe OXY-1 System instructions for use and reference manual

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Learn more about the features of the OXY-1 System

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Abiomed Breethe OXY-1 System Device Indication & Safety Information

Indications for Use

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.

Intended Users

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.

Important Risk Information

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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