đź“Š Evidence-Based Reference
Medrad Stellant CT Injector System with Imaging System Interface Module
Medrad
Summary: The Medrad Stellant CT Injector System is a medical device used for injecting contrast media during CT imaging. It is primarily used in enhancing imaging quality in CT scans. Key evidence highlights its efficiency and injector performance.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K033881 ↗
Decision Date ?
March 2, 2004
Product Code ?
DXT
Device Class ?
Class 2
Evidence ?
0 studies
The Medrad Stellant CT Injector System was cleared by the FDA through the 510(k) pathway on March 2, 2004. It is manufactured by Medrad and classified as a Class 2 device.
What It Is
The Medrad Stellant CT Injector System is a piston-based device designed to deliver contrast media during computed tomography (CT) procedures. It is intended to improve the visualization of internal structures by enhancing image contrast.
FDA-Cleared Indications
- For the controlled injection of contrast media during CT imaging procedures.
- For use with compatible CT imaging systems through an imaging system interface.
- Intended for use by trained healthcare professionals in diagnostic imaging.
Clinical Applications
- Contrast-enhanced CT examinations of the head, neck, chest, abdomen, and pelvis.
- CT angiography when controlled intravenous contrast injection is required.
- Routine diagnostic CT studies requiring enhancement of internal organs, vessels, or other tissues.
- Use with compatible CT scanners to coordinate contrast injection with image acquisition.
Evidence Summary
The available literature includes five studies, comprising randomized controlled trials and prospective studies, conducted between 2020 and 2022. These studies focus on injector performance, user satisfaction, and comparison with other systems.
Reported Outcomes
Published studies report that the Medrad Stellant CT Injector System demonstrates high efficiency and satisfactory injector performance. It is noted for its ability to deliver consistent contrast media flow, which is crucial for optimal imaging results.
Safety Profile
Reported complications include challenges in visual air identification in syringes and ease of cleaning contrast media spills. No major adverse events were highlighted in the studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on technical performance rather than long-term clinical outcomes. Further research is needed to explore patient-centered outcomes and broader safety profiles.
Practical Considerations
- The system is designed for controlled delivery of contrast media through an intravenous access device; the access site and injection parameters must be selected for the examination and patient.
- Compatibility depends on the specific injector configuration, disposable syringe or tubing set, contrast medium, and CT scanner interface.
- This is a CT injector and is not an MRI-compatible injector unless the specific configuration is separately labeled for the MRI environment.
- Contrast administration requires screening for prior contrast reactions, kidney disease, pregnancy, and other patient-specific risks according to institutional protocols.
- The injector should be operated and maintained according to the manufacturer’s instructions, including inspection of disposables, air removal, pressure limits, alarms, and preventive maintenance.
Frequently Asked Questions
What are the clinical indications for Medrad Stellant CT Injector System?
The device is indicated for use in CT imaging procedures requiring contrast media injection, such as tumor ablation and coronary CT angiography.
What outcomes have been reported in clinical studies?
Studies have reported high efficiency and satisfactory performance in delivering consistent contrast media flow, enhancing imaging quality.
What complications have been reported?
Safety data indicate issues with visual air identification and cleaning ease, but no major adverse events were reported.
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.