đź“Š Evidence-Based Reference
affinity 20 micron arterial blood filter with carmeda bioactive surface models cb353 cb354
Medtronic Vascular
Summary: The Affinity 20 Micron Arterial Blood Filter with Carmeda BioActive Surface is a device used in cardiovascular procedures to filter blood. It is primarily used to prevent emboli during surgery. Key evidence highlights its role in improving surgical outcomes.
FDA Clearance Information
Pathway
510K
Number
K001138 ↗
Decision Date
April 27, 2000
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on April 27, 2000. It is manufactured by Medtronic Vascular and classified as a Class 2 device.
What It Is
The Affinity 20 Micron Arterial Blood Filter is designed to filter blood during cardiovascular procedures, reducing the risk of emboli. It features a Carmeda BioActive Surface to enhance biocompatibility and reduce thrombogenicity.
Clinical Applications
This device is commonly used in cardiac surgeries where blood filtration is critical to prevent embolic events. It is particularly useful in procedures involving cardiopulmonary bypass.
Evidence Summary
The available literature includes 8 studies, comprising various study types such as RCTs and case series, conducted between 1992 and 1996. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Affinity 20 Micron Arterial Blood Filter effectively reduces embolic events during cardiac surgeries. The device's use is associated with improved surgical outcomes and reduced complications related to emboli.
Safety Profile
Reported complications include minimal adverse events, primarily related to device handling and placement. The studies indicate a favorable safety profile with no significant device-related complications.
Evidence Limitations
The evidence is limited by the small sample sizes and the dated nature of the studies. Further research is needed to validate findings in larger, more diverse populations and to assess long-term outcomes.
Frequently Asked Questions
What are the clinical indications for the Affinity 20 Micron Arterial Blood Filter?
The device is indicated for use in cardiac surgeries to filter blood and prevent embolic events.
What outcomes have been reported in clinical studies?
Studies report reduced embolic events and improved surgical outcomes with the use of the device.
What complications have been reported?
Safety data indicate minimal complications, primarily related to device handling, with no significant adverse events.
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.