📊 Evidence-Based Reference
Catheter Introducers Arterise
Summary: Catheter introducers arterise by C.R. Bard are used in vascular access procedures. Cleared by FDA in 1978, they are involved in embolization-coils clinical categories. Key evidence highlights their role in pressure waveform fidelity and flow rate management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781954 ↗
Decision Date ?
November 29, 1978
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The catheter introducers arterise by C.R. Bard were cleared through the FDA 510k pathway on November 29, 1978. They are classified as Class 2 devices under product code DYB.
What It Is
Catheter introducers arterise are medical devices designed to facilitate the insertion of catheters into the vascular system. They are primarily used in procedures requiring vascular access, such as embolization-coils interventions.
FDA-Cleared Indications
- Facilitate the introduction and placement of catheters into the vascular system.
- Provide vascular access for procedures performed with intravascular catheters, consistent with the applicable device labeling.
Clinical Applications
- Obtaining and maintaining vascular access during catheter-based diagnostic procedures.
- Providing access for interventional radiology procedures that require selective catheter placement.
- Providing access for catheter-based vascular interventions when the selected introducer is compatible with the catheter and access vessel.
Evidence Summary
The literature includes 9 studies ranging from 1985 to 2024, encompassing various study types such as RCTs and case series. These studies explore aspects like pressure wave fidelity and flow rate in catheter introducers.
Reported Outcomes
Published studies report that catheter introducers arterise maintain pressure waveform fidelity and manage flow rates effectively. They are shown to support accurate blood pressure measurements and facilitate large bore access in complex procedures.
Safety Profile
Reported complications include risks associated with large bore access, such as thrombosis and limb ischemia. These are critical considerations for clinicians using the device in interventional procedures.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of recent large-scale trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- Exact sheath, dilator, valve, and catheter compatibility depends on the specific model and size; verify the current manufacturer labeling before use.
- Access may be obtained through a peripheral artery or vein, commonly at the femoral or radial artery or the internal jugular vein, depending on the procedure.
- Use fluoroscopy, ultrasound, or other appropriate imaging guidance according to the procedure and access site.
- Potential complications include bleeding, hematoma, arterial or venous injury, thrombosis, infection, air embolism, and damage to the catheter or introducer.
- MRI safety is model-specific. Do not assume the device is MR Safe or MR Conditional without checking the labeling for the exact product; a retained introducer should generally be removed when clinically appropriate.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for catheter introducers arterise?
The device is indicated for use in vascular access procedures, particularly in interventional cardiology and radiology.
What outcomes have been reported in clinical studies?
Studies report effective pressure waveform fidelity and flow rate management, supporting accurate measurements and successful large bore access.
What complications have been reported?
Safety data indicate risks of thrombosis and limb ischemia associated with large bore access.
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.