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Minimax Plus Hollow Fiber Oxygenator with or Without Medtronic Carmeda Bioactive Surface
Medtronic Vascular
Summary: The Minimax Plus Hollow Fiber Oxygenator is a device used in neonatal extracorporeal life support. Key evidence highlights its role in maintaining perfusion quality and rapid ECMO initiation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K933586 ↗
Decision Date ?
February 7, 1994
Product Code ?
DTZ
Device Class ?
Class 2
Evidence ?
0 studies
The Minimax Plus Hollow Fiber Oxygenator was cleared by the FDA via the 510(k) pathway on February 7, 1994. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Minimax Plus Hollow Fiber Oxygenator is designed for use in extracorporeal life support systems, particularly for neonates. It facilitates gas exchange by using hollow fiber membranes, ensuring adequate oxygenation during critical care procedures.
FDA-Cleared Indications
- Use as a hollow-fiber membrane oxygenator in an extracorporeal life-support system.
- Support extracorporeal gas exchange by oxygenating blood and removing carbon dioxide during cardiopulmonary support.
- Use in neonatal and pediatric patients when extracorporeal life support is clinically indicated, according to the specific cleared labeling and circuit configuration.
Clinical Applications
- Neonatal ECMO for temporary respiratory support.
- Pediatric ECMO for temporary respiratory support.
- Extracorporeal cardiopulmonary support requiring membrane oxygenation.
- Gas exchange within an extracorporeal life-support circuit during critical care.
Reported off-label uses
- Use in adult extracorporeal life support may occur in clinical practice when the device size and labeling do not specifically cover the patient population; this should not be interpreted as an FDA-cleared indication.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes four studies, primarily focusing on the device's performance in neonatal ECMO. These studies span from 1997 to 2010 and include various study designs.
Reported Outcomes
Published studies report that the Minimax Plus Hollow Fiber Oxygenator provides effective perfusion quality in neonatal ECMO settings. It is noted for its rapid response capabilities, which are crucial in time-sensitive clinical scenarios. The device's performance in maintaining gas exchange efficiency has been positively evaluated in comparative studies.
Safety Profile
Reported complications include potential decreases in oxygenator efficiency due to saturation of microporous fibers and concerns about sterility when pre-primed for extended periods. However, no specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed outcomes and safety data. Further research is needed to explore long-term efficacy and safety in diverse clinical settings.
Practical Considerations
- The oxygenator must be matched to the patient's size, blood-flow requirements, extracorporeal circuit, and the manufacturer's instructions for use.
- It is used with compatible tubing, pumps, heat exchangers, monitors, and other ECMO components; compatibility should be confirmed before setup.
- The device requires careful priming, de-airing, anticoagulation management, and monitoring for clot formation, gas-exchange failure, leaks, and pressure changes.
- The Carmeda bioactive surface is a device-surface treatment and does not eliminate the need for clinical anticoagulation or monitoring.
- MRI safety should not be assumed. The oxygenator and complete extracorporeal circuit should be kept out of the MRI environment unless the specific labeling confirms conditional use.
Frequently Asked Questions
What are the clinical indications for Minimax Plus Hollow Fiber Oxygenator?
The device is indicated for use in neonatal and pediatric extracorporeal membrane oxygenation (ECMO) to support patients with respiratory or cardiac failure.
What outcomes have been reported in clinical studies?
Studies report effective perfusion quality and rapid ECMO initiation capabilities, crucial for critically ill neonates.
What complications have been reported?
Safety data indicate potential efficiency decreases and sterility concerns with prolonged pre-priming, but specific adverse events were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.