đź“Š 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
510K
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.
Clinical Applications
Commonly used in procedures such as percutaneous endoscopic gastrostomy and transapical structural and valve interventions, the introducer percutaneous is vital in settings requiring precise and safe access to internal structures.
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.
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.