đź“Š Evidence-Based Reference
affinity pediatric arterial filter model s4014 and with carmeda bioactive surface model cb4014
Medtronic Vascular
Summary: The Affinity Pediatric Arterial Filter by Medtronic is designed for use in pediatric cardiopulmonary bypass procedures. It is FDA 510k cleared and has been studied for its ability to trap gaseous microemboli. Key evidence includes its performance in simulated CPB models.
FDA Clearance Information
Pathway
510K
Number
K071253 ↗
Decision Date
July 3, 2007
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity Pediatric Arterial Filter, manufactured by Medtronic Vascular, was cleared via the FDA 510k pathway on July 3, 2007. It is classified as a Class 2 device under product code DTM.
What It Is
The Affinity Pediatric Arterial Filter is a medical device used in pediatric cardiopulmonary bypass (CPB) procedures. It is designed to filter out microemboli and other particulates from the blood, reducing the risk of embolic events during surgery.
Clinical Applications
This device is commonly used in pediatric cardiac surgeries requiring CPB, where it helps to maintain blood purity and prevent complications associated with emboli. It is particularly relevant in scenarios where the risk of gaseous microemboli is a concern.
Evidence Summary
The available literature includes two studies, one from 2008 and another from 2016. These studies explore the device's efficacy in trapping gaseous microemboli and its interaction with coagulation factors. The studies vary in design, including simulated CPB models.
Reported Outcomes
Published studies report that the Affinity Pediatric Arterial Filter effectively traps gaseous microemboli in simulated CPB models. The device's performance was evaluated under different flow conditions, demonstrating its capability to maintain postfilter pressure and reduce embolic load.
Safety Profile
Reported complications include the potential for incomplete emboli trapping under certain flow conditions. However, specific adverse events were not detailed in the available studies, indicating a need for further safety evaluations.
Evidence Limitations
The evidence is limited by the small number of studies and the use of simulated models rather than clinical trials. Further research is needed to confirm efficacy and safety in diverse clinical settings and patient populations.
Frequently Asked Questions
What are the clinical indications for Affinity Pediatric Arterial Filter?
The device is indicated for use in pediatric cardiopulmonary bypass procedures to filter out microemboli and particulates from the blood.
What outcomes have been reported in clinical studies?
Studies have shown the device's capability to trap gaseous microemboli effectively in simulated CPB models.
What complications have been reported?
Reported complications include the potential for incomplete emboli trapping, though specific adverse events were not detailed in the studies.
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.