📊 Evidence-Based Reference
Emma
Inrange Systems
Summary: emma is a device used in embolization-microspheres and y90-radioembolization. It is FDA-cleared under 510k. Key evidence includes technical validation studies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K150174 ↗
Decision Date ?
February 26, 2015
Product Code ?
NZH
Device Class ?
Class 2
Evidence ?
0 studies
emma was cleared by the FDA through the 510k pathway on February 26, 2015. It is manufactured by Inrange Systems and classified as a Class 2 device.
What It Is
emma is a medical device designed for use in embolization-microspheres and y90-radioembolization procedures. It assists in delivering therapeutic agents to targeted areas in the body.
FDA-Cleared Indications
- Use in embolization-microsphere procedures.
- Use in Y-90 radioembolization procedures.
Clinical Applications
- Delivery of embolization microspheres during image-guided embolization procedures.
- Support of Y-90 radioembolization procedures for delivering radioactive microspheres to selected target vessels.
- Use during transarterial radioembolization procedures performed through catheter-based vascular access.
Evidence Summary
The available literature includes 15 studies, with a mix of technical validation and other types of research. The studies range from 2021 to 2025.
Reported Outcomes
Published studies report on the technical validation of the emma device, particularly its accuracy under specific conditions such as hyperbaric environments. However, detailed efficacy outcomes specific to embolization or radioembolization are not extensively covered in the provided evidence.
Safety Profile
Reported complications include potential issues with device accuracy in certain environments, such as hyperbaric conditions. No other specific safety data is detailed in the provided evidence.
Evidence Limitations
The evidence lacks comprehensive clinical trials directly assessing the efficacy and safety of emma in its intended clinical applications. Further research is needed to establish detailed clinical outcomes and safety profiles.
Practical Considerations
- Use requires appropriate catheter and delivery-system compatibility; compatibility should be confirmed in the current manufacturer instructions for use.
- The device is used with fluoroscopic or other image guidance by trained clinicians familiar with embolization and radioembolization techniques.
- Handling and preparation depend on the therapeutic agent or microsphere product being delivered.
- MRI safety information is not provided in the available FDA record; consult the current labeling before MRI exposure.
- Contraindications, particle-size selection, and embolization risks are determined by the delivered agent, target anatomy, and the applicable product labeling.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for emma?
emma is indicated for use in embolization-microspheres and y90-radioembolization procedures.
What outcomes have been reported in clinical studies?
Technical validation under hyperbaric conditions has been reported, but specific clinical outcomes are not detailed in the provided studies.
What complications have been reported?
Safety data indicates potential accuracy issues in hyperbaric environments, but other complications are not detailed in the evidence.
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.