📊 Evidence-Based Reference
Envoy Guiding Catheter
Codman & Shurtleff
Summary: The Envoy Guiding Catheter by Codman & Shurtleff is used primarily for endovascular procedures. Key evidence highlights its use in complex catheterizations and embolization techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140307 ↗
Decision Date ?
April 21, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Envoy Guiding Catheter was cleared by the FDA through the 510(k) pathway on April 21, 2014. It is manufactured by Codman & Shurtleff and classified as a Class II device.
What It Is
The Envoy Guiding Catheter is a medical device designed to facilitate the delivery of diagnostic and therapeutic agents in endovascular procedures. It is used to provide support and access to the vascular system, particularly in neurovascular interventions.
FDA-Cleared Indications
- Use in percutaneous endovascular procedures to provide access to the vascular system.
- Use to facilitate the delivery of diagnostic or therapeutic agents and other interventional devices.
- Use when catheter support and selective vascular access are needed during endovascular treatment.
Clinical Applications
- Providing a stable conduit for delivery of microcatheters and other interventional devices.
- Supporting selective catheterization during diagnostic angiography.
- Facilitating delivery of therapeutic agents during endovascular procedures.
- Providing access and support during embolization procedures when consistent with the device labeling.
Reported off-label uses
- Use as a large-bore support catheter in selected peripheral or venous endovascular interventions, when appropriate for the catheter's specifications and anatomy.
- Use for selected thrombectomy or venous intervention workflows as an access and support catheter, when the device is compatible with the planned procedure.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes four studies ranging from 1997 to 2020, encompassing case series and other study types. These studies explore the catheter's use in complex embolization procedures and its thrombogenicity.
Reported Outcomes
Published studies report successful use of the Envoy Guiding Catheter in embolization procedures, including the treatment of ruptured lenticulostriate artery aneurysms. The catheter's design allows for effective manipulation and support during balloon-assisted coiling.
Safety Profile
Reported complications include difficulties in catheterization due to acute angulation of arteries. The thrombogenicity of the catheter has been assessed, with findings indicating variability based on catheter material and coating.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to establish long-term outcomes and to explore the catheter's performance in a broader range of clinical scenarios.
Practical Considerations
- The available catheter size, working length, inner diameter, outer diameter, and curve must match the target anatomy and the devices being passed through it.
- Use fluoroscopic or other appropriate imaging guidance, with continuous monitoring of catheter position and vessel response.
- Compatibility with guidewires, microcatheters, contrast agents, embolic materials, and therapeutic devices should be confirmed before use.
- Potential complications include vascular injury, dissection, perforation, thrombosis, embolization, infection, bleeding, and contrast-related reactions.
- MRI safety depends on the exact model and labeling; verify the current device-specific MRI conditions before an MRI examination. The catheter is generally intended for temporary procedural use rather than long-term implantation.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for the Envoy Guiding Catheter?
The Envoy Guiding Catheter is indicated for use in endovascular procedures, particularly in neurovascular interventions requiring precise catheter placement.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful outcomes in embolization procedures, including the treatment of aneurysms with the Envoy Guiding Catheter.
What complications have been reported?
Reported complications include difficulties in catheterization due to acute angulation and thrombogenicity related to catheter material and coating.
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.