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affinity nt oxygenator affinity nt oxygenator with trillium biosurface affinity nt oxygenator with carmeda biosurface
Medtronic
Summary: The Affinity NT Oxygenator, manufactured by Medtronic, is used in extracorporeal circulation during cardiac surgery. Key evidence highlights its efficacy in minimizing cerebral injury through microbubble filtration.
FDA Clearance Information
Pathway
510K
Number
K143073 ↗
Decision Date
March 25, 2015
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Oxygenator was cleared by the FDA via the 510(k) pathway on March 25, 2015. It is manufactured by Medtronic and classified as a Class 2 device.
What It Is
The Affinity NT Oxygenator is a medical device used in extracorporeal circulation to oxygenate blood during cardiac surgery. It features biosurfaces like Trillium and Carmeda to enhance biocompatibility and reduce complications.
Clinical Applications
Commonly used in cardiac surgeries requiring extracorporeal circulation, the Affinity NT Oxygenator helps maintain oxygenation and filtration of blood, reducing the risk of air embolism and particulate matter transmission.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs and other study types, focusing on the device's safety and efficacy. The studies span from 2015 to 2022, providing a comprehensive overview of its clinical performance.
Reported Outcomes
Published studies report that the Affinity NT Oxygenator effectively reduces microbubble transmission, thereby minimizing cerebral injury risk during cardiac procedures. Its integrated arterial filter system is shown to be as effective as separate systems in clinical settings.
Safety Profile
Reported complications include potential air embolism and particulate matter transmission, though these are minimized with the device's integrated arterial filter. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more long-term outcome data. Further research is needed to explore the device's performance in diverse patient populations and complex surgical scenarios.
Frequently Asked Questions
What are the clinical indications for Affinity NT Oxygenator?
The device is indicated for use in extracorporeal circulation during cardiac surgeries to oxygenate blood and reduce microbubble transmission.
What outcomes have been reported in clinical studies?
Studies report effective reduction in microbubble transmission and comparable safety to other oxygenators with separate arterial filters.
What complications have been reported?
Safety data indicate low incidence of air embolism and particulate matter transmission, with the integrated filter system mitigating these risks.
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.