đź“Š Evidence-Based Reference
affinity nt hollow fiber oxygenator with plasma resistant fiber with balance biocompatible surface model 511b
Medtronic Vascular
Summary: The Affinity NT Hollow Fiber Oxygenator by Medtronic Vascular is designed for cardiopulmonary bypass procedures. Key evidence highlights its effective oxygen delivery and low pressure drop.
FDA Clearance Information
Pathway
510K
Number
K992910 ↗
Decision Date
September 15, 1999
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Affinity NT Hollow Fiber Oxygenator was cleared by the FDA via the 510(k) pathway on September 15, 1999. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Affinity NT Hollow Fiber Oxygenator is a medical device used in cardiopulmonary bypass procedures. It utilizes a hollow fiber membrane to facilitate gas exchange, providing oxygenation and carbon dioxide removal during surgery.
Clinical Applications
Commonly used in cardiac surgeries requiring cardiopulmonary bypass, such as valve replacements and coronary artery bypass grafting. It is particularly useful in managing patients with high oxygen demands.
Evidence Summary
The literature includes three studies from 2002 to 2014, comprising case reports and comparative evaluations. These studies assess the device's performance in oxygen delivery and pressure drop.
Reported Outcomes
Published studies report that the Affinity NT Hollow Fiber Oxygenator effectively meets oxygen needs, even in patients with high body mass indices. It demonstrates a low transoxygenator pressure drop, comparable to other leading oxygenators.
Safety Profile
Reported complications include potential hemolysis and platelet damage due to trans-membrane pressure drop, although specific adverse events were not detailed in the studies provided.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety 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, particularly in cardiac surgeries requiring efficient oxygenation and carbon dioxide removal.
What outcomes have been reported in clinical studies?
Studies report effective oxygen delivery and low pressure drop, with performance comparable to other leading oxygenators.
What complications have been reported?
Safety data indicate potential for hemolysis and platelet damage due to pressure drop, though specific adverse events were not detailed.
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.