📊 Evidence-Based Reference
Envoy Guiding Catheters
Codman & Shurtleff
Summary: Envoy guiding catheters are used for endovascular procedures, particularly in neurointerventions. Key evidence highlights their use in anterior circulation aneurysms with a focus on supportability and navigability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093184 ↗
Decision Date ?
November 6, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Envoy guiding catheters were cleared through the FDA 510(k) pathway on November 6, 2009. Manufactured by Codman & Shurtleff, they are classified as Class 2 devices.
What It Is
Envoy guiding catheters are designed for use in endovascular procedures, providing support and navigability for devices used in neurointerventions. They are intended for accessing cerebral vasculature to facilitate therapeutic interventions.
FDA-Cleared Indications
- Used to introduce and guide interventional devices during percutaneous endovascular procedures.
- Used to provide access to the cerebral vasculature for diagnostic or therapeutic procedures.
- FDA-cleared as a Class II percutaneous catheter under product code DQY and 21 CFR 870.1250.
Clinical Applications
- Guiding microcatheters and other compatible devices into the cerebral circulation.
- Providing proximal support during endovascular treatment of intracranial vascular conditions, including procedures such as aneurysm embolization when consistent with the device labeling.
- Accessing cerebral arteries during catheter-based neurointerventional procedures.
Reported off-label uses
- Use as a guide catheter for selected extracranial or noncerebral endovascular procedures has been described in clinical practice, but this may fall outside the device labeling and should be evaluated by the treating physician.
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 literature includes 10 studies, comprising RCTs, prospective, retrospective, and case series, published between 2016 and 2024. These studies evaluate the catheter's performance in various neurovascular procedures.
Reported Outcomes
Published studies report that Envoy guiding catheters provide sufficient support and navigability for endovascular coiling of anterior circulation aneurysms. They are also noted for their feasibility in transradial neurointerventions with high procedural success rates.
Safety Profile
Reported complications include low access site complication rates in transradial approaches. Overall, the device is associated with a favorable safety profile in the studies reviewed.
Evidence Limitations
Evidence gaps include limited data on long-term outcomes and a need for larger, multicenter trials to validate findings. Some studies are single-center experiences, which may limit generalizability.
Practical Considerations
- The catheter's French size, inner diameter, outer diameter, length, and distal configuration must be matched to the planned access route and compatible guidewires, microcatheters, and other devices.
- These catheters are typically introduced through arterial access, commonly the femoral or radial artery, and advanced under fluoroscopic guidance.
- The product-specific instructions for use should be checked for compatibility, maximum pressure or injection limits, preparation, and handling requirements.
- MRI safety depends on the exact model and labeling; do not assume an implanted or retained catheter is MRI safe without confirming the current manufacturer instructions.
- Potential complications include vascular injury, dissection, perforation, thrombosis, embolization, bleeding, infection, vasospasm, and contrast-related reactions.
Frequently Asked Questions
What are the clinical indications for Envoy guiding catheters?
Envoy guiding catheters are indicated for use in endovascular procedures, particularly in neurointerventions such as coil embolization of cerebral aneurysms.
What outcomes have been reported in clinical studies?
Studies report high procedural success rates and effective support and navigability in neurovascular procedures, particularly in anterior circulation aneurysms.
What complications have been reported?
Safety data indicate low access site complication rates, particularly in transradial approaches, with an overall favorable safety profile.
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.