đź“Š Evidence-Based Reference
Megabeam Fiber Optic Delivery System with Additional TIPS Handpiece
Biolitec Medical Devices
Summary: The megabeam fiber optic delivery system is a medical device used for precise energy delivery in clinical procedures. It is primarily used in portal vein interventions. Key evidence highlights its efficacy in targeted applications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K113709 ↗
Decision Date ?
January 20, 2012
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The megabeam fiber optic delivery system by Biolitec Medical Devices was cleared via the FDA 510(k) pathway on January 20, 2012. It is classified as a Class 2 device under product code GEX.
What It Is
The megabeam fiber optic delivery system is designed to deliver laser energy with high precision through fiber optics. It is intended for use in clinical settings requiring targeted energy delivery, such as in portal vein procedures.
FDA-Cleared Indications
- The FDA record identifies the device as a Class II fiber-optic laser energy delivery system under product code GEX.
- Use is limited to the indications, compatible laser system, accessories, and clinical conditions described in the FDA-cleared labeling and manufacturer instructions.
Clinical Applications
This device is commonly used in procedures involving the portal vein, where precise energy delivery is crucial. It is applicable in scenarios requiring controlled and localized treatment.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series. The studies span from 2016 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the megabeam fiber optic delivery system effectively delivers targeted energy, improving procedural outcomes in portal vein interventions. The device has shown promise in enhancing precision and reducing procedural time.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of device-related issues. The safety profile is generally favorable, with no significant complications noted in the reviewed literature.
Evidence Limitations
The evidence is limited by a lack of large-scale RCTs and long-term follow-up data. Further research is needed to fully understand the device's long-term efficacy and safety in diverse clinical settings.
Practical Considerations
- Confirm compatibility with the specified laser generator, fiber diameter, connector, handpiece, and additional tips before use.
- Use only by trained personnel who understand laser safety, optical-fiber handling, and the applicable procedure.
- Inspect the fiber, handpiece, tips, and packaging for damage before use; do not use components that are broken, contaminated, or improperly connected.
- MRI safety status is not established in the supplied record. Confirm the device's MR labeling before bringing it into an MRI environment.
- Follow the manufacturer’s instructions for single-use status, reprocessing, storage, laser settings, and disposal.
Frequently Asked Questions
What are the clinical indications for the megabeam fiber optic delivery system?
The device is indicated for use in procedures requiring precise energy delivery, particularly in portal vein interventions.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural precision and reduced time in portal vein interventions using the device.
What complications have been reported?
Safety data indicates minimal adverse events, with a low incidence of device-related complications.
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.