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affinity nt oxygenator affinity nt oxygenator with trillium biosurface
Medtronic
Summary: The Affinity NT Oxygenator with Trillium Biosurface is a medical device used in extracorporeal circulation during cardiac surgery. It is primarily used to oxygenate and remove carbon dioxide from the blood. Key evidence highlights its efficacy in reducing microbubble transmission.
FDA Clearance Information
Pathway
510K
Number
K162896 ↗
Decision Date
December 6, 2016
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Oxygenator was cleared by the FDA through the 510(k) pathway on December 6, 2016. It is manufactured by Medtronic and classified as a Class 2 device under product code DTZ.
What It Is
The Affinity NT Oxygenator is designed to oxygenate blood and remove carbon dioxide during extracorporeal circulation in cardiac surgeries. It features Trillium Biosurface technology to enhance biocompatibility and reduce blood activation.
Clinical Applications
Commonly used in cardiac surgeries requiring cardiopulmonary bypass, the Affinity NT Oxygenator is integral in maintaining oxygenation and carbon dioxide removal when the heart and lungs are temporarily non-functional.
Evidence Summary
The available literature includes 10 studies, with a mix of randomized controlled trials and observational studies, published between 2015 and 2022. These studies explore various aspects of the device's performance and safety.
Reported Outcomes
Published studies report that the Affinity NT Oxygenator effectively reduces microbubble transmission compared to other oxygenators. It is associated with efficient oxygenation and carbon dioxide removal during cardiopulmonary bypass procedures.
Safety Profile
Reported complications include potential microbubble transmission, although studies indicate that the Affinity NT Oxygenator performs well in minimizing this risk. No significant adverse events directly attributed to the device were noted in the reviewed literature.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the Affinity NT Oxygenator. Further research is needed to explore long-term outcomes and comparative effectiveness against newer oxygenator models.
Frequently Asked Questions
What are the clinical indications for Affinity NT Oxygenator?
The Affinity NT Oxygenator is indicated for use in extracorporeal circulation during cardiac surgeries to oxygenate blood and remove carbon dioxide.
What outcomes have been reported in clinical studies?
Studies report effective oxygenation and carbon dioxide removal, with reduced microbubble transmission compared to other devices.
What complications have been reported?
Safety data indicate potential microbubble transmission, but no significant adverse events directly linked to the device were reported.
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.