đź“Š Evidence-Based Reference
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Medtronic
Summary: The Affinity NT Oxygenator by Medtronic is a device used in extracorporeal circulation during cardiac surgery. It is FDA 510k cleared and supported by 10 studies, highlighting its safety and efficacy in reducing microbubble transmission.
FDA Clearance Information
Pathway
510K
Number
K183490 ↗
Decision Date
April 12, 2019
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Oxygenator, manufactured by Medtronic, received FDA clearance through the 510k pathway on April 12, 2019. It is classified as a Class 2 device under product code DTZ.
What It Is
The Affinity NT Oxygenator is designed for use in extracorporeal circulation during cardiac surgery. It facilitates gas exchange and blood filtration, with options for Trillium or Cortiva bioactive surfaces to enhance biocompatibility.
Clinical Applications
Commonly used in cardiac surgeries requiring cardiopulmonary bypass, the Affinity NT Oxygenator helps maintain oxygenation and carbon dioxide removal. It is suitable for procedures where minimizing microbubble transmission is critical.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials and other designs, published between 2015 and 2022. These studies evaluate the device's performance in clinical settings, focusing on safety and efficacy.
Reported Outcomes
Published studies report that the Affinity NT Oxygenator effectively reduces microbubble transmission compared to older models. It maintains adequate oxygenation and carbon dioxide removal during cardiac procedures, contributing to improved patient outcomes.
Safety Profile
Reported complications include minimal adverse events related to microbubble transmission. The integrated arterial filter in the Fusion model enhances safety by capturing particulate matter.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for long-term follow-up studies. Further research is needed to explore the device's performance in diverse patient populations and complex surgical scenarios.
Frequently Asked Questions
What are the clinical indications for Affinity NT Oxygenator?
The device is indicated for use in extracorporeal circulation during cardiac surgery, particularly where minimizing microbubble transmission is important.
What outcomes have been reported in clinical studies?
Studies have shown effective reduction in microbubble transmission and maintenance of gas exchange during cardiac procedures.
What complications have been reported?
Safety data indicate minimal complications, primarily related to microbubble transmission, which are mitigated by the integrated arterial filter.
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.