📊 Evidence-Based Reference
Durasheath Introducer Sheath System
Summary: The Durasheath Introducer Sheath System is a medical device used primarily in embolization procedures. It is designed to facilitate the introduction of catheters and other devices into the vascular system. Key evidence highlights its utility in minimally invasive procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181463 ↗
Decision Date ?
December 13, 2018
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Durasheath Introducer Sheath System was cleared by the FDA through the 510(k) pathway on December 13, 2018. It is manufactured by Contract Medical International and classified as a Class 2 device.
What It Is
The Durasheath Introducer Sheath System is a vascular access device that provides a conduit for the insertion of catheters and other medical instruments into the vascular system. It is intended for use in procedures requiring vascular access, such as embolization.
FDA-Cleared Indications
- Provides vascular access for the introduction of catheters and other intravascular devices.
- Is intended for use during procedures requiring access to the vascular system, including embolization procedures.
Clinical Applications
- Obtaining and maintaining vascular access during catheter-based embolization.
- Introducing diagnostic or therapeutic catheters into the arterial or venous circulation.
- Supporting minimally invasive interventional radiology procedures that require a stable vascular conduit.
- Providing access for catheter-directed treatment of selected vascular abnormalities or bleeding sources.
Evidence Summary
The available literature includes 10 peer-reviewed studies, encompassing various study types such as RCTs and case series, conducted between 2024 and 2025. These studies explore the device's application in different clinical settings.
Reported Outcomes
Published studies report that the Durasheath Introducer Sheath System is effective in facilitating vascular access with minimal complications. It has been shown to improve procedural efficiency in embolization and other interventional procedures. Clinical outcomes indicate a reduction in procedure time and enhanced patient comfort.
Safety Profile
Reported complications include potential issues such as radial artery spasm and occlusion, which are common in transradial access procedures. However, the overall safety profile is favorable, with low incidence of severe adverse events.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to assess long-term outcomes and to compare the device's efficacy with alternative sheath systems.
Practical Considerations
- The appropriate sheath size and length depend on the access vessel, target anatomy, and outside diameter of the catheter or device being introduced.
- The sheath must be compatible with the selected guidewire, catheter, and other intravascular equipment; users should confirm the product labeling before use.
- Access is commonly obtained percutaneously through a peripheral artery or vein using sterile technique and imaging guidance when appropriate.
- Potential complications include bleeding, hematoma, vessel injury, thrombosis, infection, embolization, and contrast-related complications from the overall procedure.
- MRI safety and conditions should be confirmed in the current manufacturer labeling; do not assume the sheath is MR Safe or MR Conditional without device-specific documentation.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Durasheath Introducer Sheath System?
The device is indicated for use in procedures requiring vascular access, such as embolization and other interventional radiology and cardiology procedures.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural efficiency, reduced procedure time, and enhanced patient comfort with the use of the Durasheath Introducer Sheath System.
What complications have been reported?
Safety data indicate potential complications such as radial artery spasm and occlusion, though these are generally infrequent and manageable.
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.