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affinity fusion oxygenator with integrated arterial filter and balance biosurface affinity fusion oxygenator with integrated arterial filter and carmeda bioactive surface
Medtronic
Summary: The Affinity Fusion Oxygenator by Medtronic is a device used in cardiopulmonary bypass procedures, integrating an arterial filter and biocompatible surface. Key evidence highlights its role in reducing systemic inflammatory response and coagulopathy.
FDA Clearance Information
Pathway
510K
Number
K142784 ↗
Decision Date
October 24, 2014
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Fusion Oxygenator was cleared by the FDA through the 510k pathway on October 24, 2014. It is manufactured by Medtronic and classified as a Class 2 device.
What It Is
The Affinity Fusion Oxygenator is a medical device designed for use in cardiopulmonary bypass procedures. It integrates an arterial filter and features a biocompatible surface to enhance blood compatibility and reduce inflammatory responses.
Clinical Applications
This device is commonly used in cardiac surgeries requiring extracorporeal circulation, where it helps manage oxygenation and filtration of blood. It is particularly useful in reducing complications associated with systemic inflammatory response syndrome.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2017 and 2023. These studies explore clinical and hematological outcomes associated with the device.
Reported Outcomes
Published studies report that the Affinity Fusion Oxygenator effectively reduces the incidence of gaseous microemboli and associated neurocognitive dysfunction post-cardiac surgery. It also demonstrates improved biocompatibility, reducing systemic inflammatory response and coagulopathy.
Safety Profile
Reported complications include the potential for gaseous microemboli formation, which can lead to neurocognitive issues. However, the device's design aims to mitigate these risks through enhanced filtration and biocompatibility.
Evidence Limitations
Current evidence is limited by the variability in study designs and the need for larger, multicenter trials to confirm findings. Further research is needed to explore long-term outcomes and comparative effectiveness with other oxygenators.
Frequently Asked Questions
What are the clinical indications for Affinity Fusion Oxygenator?
The device is indicated for use in cardiopulmonary bypass procedures during cardiac surgery to manage oxygenation and filtration of blood.
What outcomes have been reported in clinical studies?
Studies report reduced gaseous microemboli and improved biocompatibility, leading to decreased systemic inflammatory response and coagulopathy.
What complications have been reported?
Safety data indicate potential for gaseous microemboli, but the device's design helps mitigate 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.