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catheter introducer sheath
Edwards Lifesciences
Summary: The catheter introducer sheath by Edwards Lifesciences is used for vascular access in various clinical procedures. Key evidence highlights its role in reducing surgical trauma and complications in specific settings.
FDA Clearance Information
Pathway
510K
Number
K131627 ↗
Decision Date
March 6, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer sheath was cleared by the FDA via the 510k pathway on March 6, 2014. It is manufactured by Edwards Lifesciences and classified as a Class 2 device.
What It Is
The catheter introducer sheath is a medical device designed to facilitate the insertion of catheters into blood vessels. It is commonly used in procedures requiring vascular access, such as the placement of pulmonary artery catheters.
Clinical Applications
This device is frequently used in procedures like hepatic venous pressure gradient measurement and pediatric endoscopic skull base surgery. It provides a conduit for catheters, minimizing trauma to vascular and surrounding tissues.
Evidence Summary
The literature includes 14 studies, comprising RCTs, case reports, and retrospective analyses, published between 1989 and 2020. These studies explore various clinical applications and outcomes associated with the device.
Reported Outcomes
Published studies report that the catheter introducer sheath effectively facilitates catheter placement with reduced trauma in pediatric endoscopic procedures. It also supports accurate measurements in hepatic venous pressure gradient assessments.
Safety Profile
Reported complications include vein perforation during insertion, as highlighted in a case report. Other studies suggest the device generally reduces nasal trauma in pediatric surgeries.
Evidence Limitations
Current evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for catheter introducer sheath?
The catheter introducer sheath is indicated for use in procedures requiring vascular access, such as hepatic venous pressure gradient measurement and pediatric endoscopic skull base surgery.
What outcomes have been reported in clinical studies?
Studies report effective catheter placement with reduced trauma in specific procedures, such as pediatric endoscopic surgeries and hepatic venous pressure assessments.
What complications have been reported?
Safety data indicate potential complications like vein perforation during insertion, although the device generally reduces trauma in other contexts.
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.