📊 Evidence-Based Reference
Introducer Percutaneous
Med Fusion Systems
Summary: The introducer percutaneous by Med Fusion Systems is a device used primarily for procedures involving embolization coils. Key evidence highlights its application in percutaneous endoscopic gastrostomy and other interventional procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K870907 ↗
Decision Date ?
April 9, 1987
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The introducer percutaneous was cleared by the FDA through the 510(k) pathway on April 9, 1987. It is manufactured by Med Fusion Systems and classified as a Class 2 medical device.
What It Is
The introducer percutaneous is a medical device designed to facilitate the insertion of embolization coils and other interventional tools through the skin. It is used in various clinical settings to enable minimally invasive procedures.
FDA-Cleared Indications
- Facilitates percutaneous introduction of embolization coils and other interventional devices into the body.
- Provides access for minimally invasive procedures when an introducer is required to deliver the indicated device.
Clinical Applications
- Percutaneous access for delivery of embolization coils.
- Access for interventional procedures involving catheter-based treatment of blood vessels.
- Access used during selected percutaneous endoscopic gastrostomy procedures when compatible with the procedural system.
Reported off-label uses
- Percutaneous access for selected transapical structural-heart and valve interventions, when the device is appropriately sized and compatible with the procedure.
- Access for other catheter-based embolization procedures using compatible coils or interventional tools.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies ranging from 2020 to 2022, encompassing randomized controlled trials, prospective and retrospective studies, and case series. These studies explore the device's efficacy and safety in various clinical applications.
Reported Outcomes
Published studies report that the introducer percutaneous is effective in procedures like percutaneous endoscopic gastrostomy, with success rates comparable to alternative techniques. It has been shown to facilitate safe and effective access in complex interventional procedures.
Safety Profile
Reported complications include device fragment embolization and procedural risks associated with large-sized introducer sheaths. However, studies generally support the device's safety profile when used appropriately.
Evidence Limitations
The evidence is limited by the variability in study designs and the specific clinical contexts explored. Further research is needed to establish standardized protocols and long-term outcomes across diverse patient populations.
Practical Considerations
- The appropriate introducer size depends on the diameter of the embolization coil, catheter, or other device being delivered; users should confirm compatibility with the device labeling.
- Insertion is generally performed through a percutaneous access site using a needle, guidewire, and imaging guidance as appropriate.
- The access site and vessel anatomy must be assessed for bleeding risk, stenosis, thrombosis, infection, and other contraindications to percutaneous access.
- MRI safety is not established from the available FDA record. Confirm the exact model and labeling before an MRI examination; do not assume the device is MR safe or MR conditional.
- Potential complications are related to access and device use and may include bleeding, hematoma, infection, vessel injury, thrombosis, air embolism, malposition, or inability to advance the intended device.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for introducer percutaneous?
The device is indicated for use in procedures requiring percutaneous access, such as embolization and percutaneous endoscopic gastrostomy.
What outcomes have been reported in clinical studies?
Studies report high success rates in procedures like percutaneous endoscopic gastrostomy, with outcomes comparable to alternative techniques.
What complications have been reported?
Safety data indicate risks such as device fragment embolization and procedural complications with large introducer sheaths.
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.