đź“Š Evidence-Based Reference
affinity fusion oxygenator with integrated arterial filter and balance biosurface model bb811
Medtronic
Summary: The Affinity Fusion Oxygenator with integrated arterial filter is used in cardiopulmonary bypass procedures. Key evidence highlights its role in reducing gaseous microemboli during cardiac surgery.
FDA Clearance Information
Pathway
510K
Number
K122827 ↗
Decision Date
December 14, 2012
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Fusion Oxygenator was cleared by the FDA via the 510(k) pathway on December 14, 2012. It is manufactured by Medtronic and classified as a Class 2 device.
What It Is
The Affinity Fusion Oxygenator is a medical device used in cardiopulmonary bypass procedures. It integrates an arterial filter and features a biocompatible surface to enhance patient safety during surgery.
Clinical Applications
This device is commonly used in cardiac surgeries requiring extracorporeal circulation, where it helps oxygenate blood and filter out microemboli, thus reducing the risk of postoperative complications.
Evidence Summary
The literature includes 10 studies, comprising various study designs such as RCTs and retrospective analyses, conducted between 2017 and 2024. These studies evaluate the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Affinity Fusion Oxygenator effectively reduces gaseous microemboli during cardiac surgery, potentially improving postoperative neurocognitive outcomes. It is also noted for its biocompatible surface that may mitigate systemic inflammatory response syndrome.
Safety Profile
Reported complications include the risk of gaseous microemboli, which can lead to neurocognitive dysfunction. However, the device's design aims to minimize these risks, enhancing overall safety during cardiac procedures.
Evidence Limitations
Current evidence is limited by the variability in study designs and sample sizes. Further research is needed to establish long-term outcomes and compare efficacy across different 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 surgery to oxygenate blood and filter microemboli.
What outcomes have been reported in clinical studies?
Studies report a reduction in gaseous microemboli and improved neurocognitive outcomes post-surgery.
What complications have been reported?
Safety data indicate risks of gaseous microemboli, although the device design aims to minimize such complications.
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.