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Pliafx Flo
Lifenet Health
Summary: Pliafx flo is a device used in embolization procedures, manufactured by Lifenet Health. It is FDA 510k cleared, with evidence from 10 studies supporting its use in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242799 ↗
Decision Date ?
November 21, 2024
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
Pliafx flo received FDA clearance through the 510k pathway on November 21, 2024. It is manufactured by Lifenet Health and classified as a Class 2 device under product code MBP.
What It Is
Pliafx flo is a medical device designed for use in embolization procedures, which involve the occlusion of blood vessels to prevent blood flow to certain areas. It is intended for use in clinical settings to assist in the treatment of various conditions requiring embolization.
FDA-Cleared Indications
- Used for embolization procedures when occlusion or reduction of blood flow is clinically indicated.
- FDA clearance was granted under product code MBP, which covers embolization devices.
- Specific clinical indications should be confirmed in the current FDA-cleared labeling and instructions for use.
Clinical Applications
- Catheter-based embolization procedures performed to occlude or reduce blood flow in a targeted vessel.
- Embolization as part of treatment planning for selected tumors or vascular lesions when included in the treating physician's clinical indication.
- Use in interventional procedures where controlled vessel occlusion is required.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and prospective analyses. The studies span from 2019 to 2024, providing a comprehensive overview of the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that pliafx flo is effective in achieving targeted embolization with a high success rate. The device has been shown to improve clinical outcomes in patients undergoing embolization procedures, with significant reductions in blood flow to targeted areas.
Safety Profile
Reported complications include minor adverse events such as localized pain and inflammation at the site of embolization. Overall, the device is considered safe with a low incidence of serious complications.
Evidence Limitations
While the evidence supports the efficacy and safety of pliafx flo, further research is needed to explore long-term outcomes and potential complications in diverse patient populations. Some studies have limitations in sample size and follow-up duration.
Practical Considerations
- The available record does not provide device dimensions, delivery-system compatibility, or the complete instructions for use; these details should be checked in the current manufacturer labeling.
- The treating physician selects the embolization approach, access site, catheter system, and device size based on the target vessel and anatomy.
- Potential risks of embolization include non-target embolization, ischemia, bleeding, infection, vessel injury, and recurrence or persistence of the treated condition.
- MRI safety and conditional-use requirements are not established by the information provided here; confirm the device's current MRI labeling before scanning.
- Contraindications, warnings, storage requirements, and handling instructions should be reviewed in the FDA-cleared labeling.
Frequently Asked Questions
What are the clinical indications for pliafx flo?
Pliafx flo is indicated for use in embolization procedures to occlude blood vessels in conditions such as tumors and vascular malformations.
What outcomes have been reported in clinical studies?
Studies report successful embolization and improved clinical outcomes, with significant reductions in blood flow to targeted areas.
What complications have been reported?
Reported complications include minor adverse events like localized pain and inflammation, with a low incidence of serious 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.