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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
510K
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.
Clinical Applications
This device is commonly used in neonatal and pediatric extracorporeal membrane oxygenation (ECMO) settings. It is particularly valuable in scenarios requiring rapid initiation of ECMO to prevent adverse outcomes in critically ill patients.
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.
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.