Envoy Guiding Catheter
Cordis Neurovascular
FDA Clearance Information
The Envoy Guiding Catheter was cleared by the FDA through the 510(k) pathway on July 23, 1997. It is manufactured by Cordis Neurovascular and classified as a Class II device.
What It Is
FDA-Cleared Indications
- Percutaneous use as a catheter to access and support intravascular procedures, consistent with the FDA product code DQY and 21 CFR 870.1250.
- Used to facilitate the introduction and guidance of other catheters or interventional devices within the vasculature.
Clinical Applications
- Providing a stable conduit for introducing compatible diagnostic or therapeutic catheters.
- Supporting catheter-based endovascular treatment when controlled device access and positioning are required.
Reported off-label uses
- Use as a proximal access and support catheter in neurovascular embolization procedures, including procedures involving intracranial aneurysms, may be described in clinical practice but should be verified against the specific device labeling.
- Use in selected complex peripheral or venous catheterization procedures may occur in practice, but is not established by the supplied FDA indication text and should not be assumed to be on-label.
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
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- Select the catheter diameter, length, and configuration based on the access site, target anatomy, compatible guidewire or catheter system, and the instructions for use.
- Confirm compatibility with all devices to be introduced through or alongside the catheter; do not use devices that exceed the labeled inner diameter or other compatibility limits.
- The supplied record does not state the catheter's MRI safety classification. Check current manufacturer labeling before MRI exposure.
- Potential complications are those associated with percutaneous catheterization, including bleeding, vascular injury, thrombosis, embolization, infection, contrast reaction, and vessel spasm or dissection.
- Use requires appropriate imaging guidance, sterile technique, anticoagulation or other medication management when clinically indicated, and an experienced procedural team.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Envoy Guiding Catheter?
The Envoy Guiding Catheter is indicated for use in neurovascular procedures, particularly in the guidance and support of microcatheters during interventions such as embolization and coiling of intracranial aneurysms.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful outcomes in the use of the Envoy Guiding Catheter for complex neurovascular procedures, including effective embolization and coiling of aneurysms.
What complications have been reported?
Safety data from evidence indicate that complications can include difficult catheterization due to vessel angulation, although the catheter generally supports safe navigation.