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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
510K
Number
K140307 ↗
Decision Date
April 21, 2014
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 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.
Clinical Applications
Commonly used in neurovascular procedures, the Envoy Guiding Catheter assists in the treatment of aneurysms and other vascular abnormalities. It is often employed in scenarios requiring precise catheter placement and support for microcatheters.
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.
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.