đź“Š Evidence-Based Reference
introducer percutaneous
Willson
Summary: The introducer percutaneous by Willson is a device used primarily for embolization-coils. Key evidence highlights its use in various percutaneous procedures with a focus on safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K812143 ↗
Decision Date
August 18, 1981
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer percutaneous by Willson was cleared through the FDA 510(k) pathway on August 18, 1981. It is classified as a Class 2 device under product code DYB.
What It Is
The introducer percutaneous is a medical device designed for the insertion of embolization coils and other percutaneous procedures. It facilitates access to vascular and other anatomical structures, aiding in minimally invasive interventions.
Clinical Applications
Commonly used in procedures requiring vascular access, such as embolization and percutaneous endoscopic gastrostomy. It is essential in settings where minimally invasive techniques are preferred.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2020 and 2022. These studies explore the device's efficacy and safety in clinical applications.
Reported Outcomes
Published studies report successful use of the introducer percutaneous in procedures like percutaneous endoscopic gastrostomy and transapical valve implantations. The device has shown efficacy in facilitating these interventions with favorable outcomes.
Safety Profile
Reported complications include device fragment embolization and procedural risks associated with large-sized introducer sheaths. Overall, the device is considered safe when used according to clinical guidelines.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for introducer percutaneous?
The device is indicated for use in embolization-coils and other percutaneous procedures as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported successful procedural outcomes in percutaneous endoscopic gastrostomy and transapical valve implantations.
What complications have been reported?
Safety data indicates complications such as device fragment embolization and risks associated 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.