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envoy guiding catheter
Cordis Neurovascular
Summary: The Envoy Guiding Catheter, manufactured by Cordis Neurovascular, is primarily used in neurovascular procedures. Key evidence highlights its use in complex catheterization scenarios with reported success in aneurysm treatments.
FDA Clearance Information
Pathway
510K
Number
K940187 ↗
Decision Date
March 30, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Envoy Guiding Catheter was cleared by the FDA through the 510(k) pathway on March 30, 1994. It is manufactured by Cordis Neurovascular and classified as a Class 2 device.
What It Is
The Envoy Guiding Catheter is a medical device designed to facilitate the navigation and placement of microcatheters in neurovascular procedures. It is intended for use in accessing and treating cerebral vasculature.
Clinical Applications
Commonly used in endovascular procedures, the Envoy Guiding Catheter assists in the treatment of intracranial aneurysms and other complex neurovascular conditions. It provides support for microcatheter navigation and embolization techniques.
Evidence Summary
The available literature includes four studies, ranging from case series to prospective trials, published between 1997 and 2020. These studies explore the catheter's application in neurovascular interventions.
Reported Outcomes
Published studies report successful treatment of ruptured lenticulostriate artery aneurysms using the Envoy Guiding Catheter in conjunction with embolization techniques. The catheter has been noted for its ability to facilitate complex catheterization and support embolization procedures.
Safety Profile
Reported complications include difficulties in catheterization due to acute angulation of arteries. No other significant adverse events were highlighted in the reviewed studies.
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 safety in diverse patient populations.
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 treatment of intracranial aneurysms and complex catheterization scenarios.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful aneurysm treatment and effective catheterization support in neurovascular procedures.
What complications have been reported?
Safety data from evidence indicate complications such as difficult catheterization due to acute angulation of arteries.
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.