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Medtronic Perfusion Systems
Summary: The Affinity Fusion Oxygenator is a device used in cardiopulmonary bypass procedures, integrating an arterial filter for enhanced safety. Key evidence highlights its role in reducing systemic inflammatory response and coagulopathy.
FDA Clearance Information
Pathway
510K
Number
K240666 ↗
Decision Date
July 10, 2024
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Fusion Oxygenator was cleared via the FDA 510k pathway on July 10, 2024. It is manufactured by Medtronic Perfusion Systems and classified as a Class 2 device.
What It Is
The Affinity Fusion Oxygenator is designed for use in cardiopulmonary bypass, incorporating an integrated arterial filter to improve patient outcomes by reducing embolic load. It is intended for use in cardiac surgeries requiring extracorporeal circulation.
Clinical Applications
Commonly used in cardiac surgeries, the device is employed during procedures that necessitate cardiopulmonary bypass, such as coronary artery bypass grafting and valve replacements, to ensure efficient oxygenation and filtration of blood.
Evidence Summary
The literature includes 10 studies, with a mix of retrospective analyses and prospective trials, spanning from 2017 to 2024. These studies evaluate the device's performance in clinical settings, focusing on safety and efficacy.
Reported Outcomes
Published studies report that the Affinity Fusion Oxygenator effectively reduces gaseous microemboli, which are associated with postoperative neurocognitive dysfunction. The device's biocompatible coating helps mitigate systemic inflammatory response syndrome, improving clinical outcomes in cardiac surgery.
Safety Profile
Reported complications include the risk of gaseous microemboli, although the device's design aims to minimize this. No significant adverse events directly attributed to the device were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials directly comparing the device to alternatives. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Affinity Fusion Oxygenator?
The device is indicated for use in cardiopulmonary bypass procedures during cardiac surgeries, such as coronary artery bypass grafting and valve replacements.
What outcomes have been reported in clinical studies?
Studies report reduced gaseous microemboli and improved management of systemic inflammatory response, contributing to better postoperative outcomes.
What complications have been reported?
Safety data indicate a risk of gaseous microemboli, though the device's design aims to mitigate this risk. No significant adverse events were directly linked to the device.
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.