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affinity nt hollow fiber oxygenator with plasma resistant fiber with carmeda bioactive surface model cb511
Medtronic Vascular
Summary: The Affinity NT Hollow Fiber Oxygenator with Carmeda BioActive Surface is a device used in cardiopulmonary bypass procedures. Key evidence highlights its efficacy in oxygen delivery and low trans-membrane pressure drop, making it suitable for high-risk patients.
FDA Clearance Information
Pathway
510K
Number
K000430 ↗
Decision Date
February 25, 2000
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Hollow Fiber Oxygenator was cleared by the FDA through the 510(k) pathway on February 25, 2000. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Affinity NT Hollow Fiber Oxygenator is designed for use in cardiopulmonary bypass procedures, providing efficient oxygen exchange and blood flow management. It features a plasma-resistant fiber with a Carmeda BioActive Surface to enhance biocompatibility.
Clinical Applications
Commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as valve replacements and coronary artery bypass grafting, especially in patients with complex conditions like obesity or renal failure.
Evidence Summary
The literature includes three studies ranging from 2002 to 2014, comprising case reports and comparative evaluations. These studies assess the device's performance in oxygen delivery and pressure management.
Reported Outcomes
Published studies report that the Affinity NT Hollow Fiber Oxygenator effectively meets oxygen needs even in high-risk patients, with a maximum oxygen delivery of 807.51 mL/min. It also demonstrates a low trans-membrane pressure drop, reducing risks of hemolysis and systemic inflammatory response.
Safety Profile
Reported complications include potential hemolysis and platelet damage due to trans-membrane pressure drop, although the Affinity NT showed favorable outcomes compared to other oxygenators. No significant differences in pressure drop were noted during cooling and re-warming phases.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and performance in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Affinity NT Hollow Fiber Oxygenator?
The device is indicated for use in cardiopulmonary bypass procedures during cardiac surgeries, particularly in patients with complex conditions such as obesity or renal failure.
What outcomes have been reported in clinical studies?
Studies report effective oxygen delivery and low trans-membrane pressure drop, with the device meeting normal and above-normal oxygen needs.
What complications have been reported?
Safety data indicate potential for hemolysis and platelet damage due to pressure drop, though the device performs favorably compared to others in its class.
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.