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affinity hollow fiber oxygenator with trillium biopassive surface
Avecor Cardiovascular
Summary: The Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface is a device used in cardiopulmonary bypass procedures to oxygenate blood. Key evidence includes studies on oxygen and carbon dioxide mass transfer efficiency.
FDA Clearance Information
Pathway
510K
Number
K973760 ↗
Decision Date
February 18, 1998
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity Hollow Fiber Oxygenator was cleared by the FDA through the 510(k) pathway on February 18, 1998. It is manufactured by Avecor Cardiovascular and classified as a Class 2 device.
What It Is
The Affinity Hollow Fiber Oxygenator is designed to oxygenate blood during cardiopulmonary bypass procedures. It features a Trillium Biopassive Surface to enhance biocompatibility and reduce thrombogenicity.
Clinical Applications
This device is commonly used in cardiac surgery settings where extracorporeal circulation is required. It is particularly useful in procedures necessitating temporary blood oxygenation and carbon dioxide removal.
Evidence Summary
The literature includes 10 studies, primarily focusing on the device's efficiency in oxygen and carbon dioxide mass transfer. The studies range from 2011 to 2023 and include various study designs.
Reported Outcomes
Published studies report that the Affinity Hollow Fiber Oxygenator effectively facilitates oxygen and carbon dioxide exchange. The device's design supports efficient mass transfer, crucial for maintaining physiological blood gas levels during surgery.
Safety Profile
Reported complications include potential issues related to the biocompatibility of the oxygenator surface. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence lacks detailed safety outcomes and long-term efficacy data. Further research is needed to explore the device's performance across diverse patient populations and surgical contexts.
Frequently Asked Questions
What are the clinical indications for the Affinity Hollow Fiber Oxygenator?
The device is indicated for use in cardiopulmonary bypass procedures requiring blood oxygenation and carbon dioxide removal.
What outcomes have been reported in clinical studies?
Studies highlight the device's efficiency in oxygen and carbon dioxide mass transfer during extracorporeal circulation.
What complications have been reported?
Safety data from evidence is limited, but potential biocompatibility issues with the oxygenator surface have been noted.
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.