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affinity fusion oxygenator with integrated arterial filter and carmeda bioactive surface
Medtronic
Summary: The Affinity Fusion Oxygenator with integrated arterial filter and Carmeda BioActive Surface is used in cardiopulmonary bypass procedures. Key evidence highlights its role in reducing systemic inflammatory response and managing gaseous microemboli.
FDA Clearance Information
Pathway
510K
Number
K123314 ↗
Decision Date
January 22, 2013
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on January 22, 2013. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity Fusion Oxygenator is a medical device used in cardiopulmonary bypass procedures. It integrates an arterial filter and features the Carmeda BioActive Surface to enhance biocompatibility and reduce inflammatory responses.
Clinical Applications
Commonly used during cardiac surgeries requiring extracorporeal circulation, the device helps manage systemic inflammatory response syndrome and mitigate coagulopathy by filtering blood and oxygenating it outside the body.
Evidence Summary
The literature includes 10 studies, spanning from 2017 to 2024, with various study designs including RCTs and retrospective analyses. These studies evaluate the device's clinical and hematological outcomes.
Reported Outcomes
Published studies report that the Affinity Fusion Oxygenator effectively reduces gaseous microemboli and improves perioperative outcomes in cardiac surgery. It is associated with decreased systemic inflammatory response and better management of coagulopathy.
Safety Profile
Reported complications include the potential for gaseous microemboli, which are linked to postoperative neurocognitive dysfunction. However, the device's design aims to minimize these risks.
Evidence Limitations
The evidence is limited by the lack of large-scale, long-term studies. Further research is needed to fully understand the device's impact on clinical outcomes and its comparative effectiveness against other oxygenators.
Frequently Asked Questions
What are the clinical indications for affinity fusion oxygenator?
The device is indicated for use in cardiopulmonary bypass procedures to oxygenate and filter blood, reducing systemic inflammatory response and coagulopathy.
What outcomes have been reported in clinical studies?
Studies report reduced gaseous microemboli and improved perioperative outcomes, with decreased systemic inflammatory response and better coagulopathy management.
What complications have been reported?
Reported complications include gaseous microemboli, which can lead to neurocognitive dysfunction, though the device is designed to minimize 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.