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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
510K
Number
K093184 ↗
Decision Date
November 6, 2009
Product Code
DQY
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.
Clinical Applications
Commonly used in procedures such as coil embolization of cerebral aneurysms and transradial neurointerventions, Envoy guiding catheters are integral in providing access and support in complex vascular territories.
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.
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.