đź“Š Evidence-Based Reference
envoy distal access guiding catheter
Codman & Shurtleff
Summary: The Envoy Distal Access Guiding Catheter by Codman & Shurtleff is used primarily in endovascular procedures for cerebral aneurysms. Key evidence highlights its supportability and navigability in anterior circulation aneurysms.
FDA Clearance Information
Pathway
510K
Number
K120229 ↗
Decision Date
February 24, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Envoy Distal Access Guiding Catheter was cleared by the FDA via the 510(k) pathway on February 24, 2012. It is manufactured by Codman & Shurtleff and classified as a Class II device.
What It Is
The Envoy Distal Access Guiding Catheter is designed to provide support and distal navigability in endovascular procedures. It is primarily used for accessing cerebral vasculature in the treatment of aneurysms.
Clinical Applications
Commonly used in endovascular coiling of anterior circulation cerebral aneurysms, the catheter facilitates access to distal vasculature. It is also utilized in trans-radial approaches for middle meningeal artery embolization.
Evidence Summary
The literature includes five studies, comprising RCTs, prospective, retrospective, and case series, published between 2020 and 2024. These studies explore the catheter's use in various endovascular procedures.
Reported Outcomes
Published studies report that the Envoy Distal Access Guiding Catheter provides sufficient support and navigability for endovascular coiling of cerebral aneurysms. Successful treatment of ruptured lenticulostriate artery aneurysms has been documented.
Safety Profile
Reported complications include difficult catheterization due to acute angulation at the artery origin. No other significant adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Envoy Distal Access Guiding Catheter?
The catheter is indicated for use in endovascular procedures, particularly for accessing cerebral vasculature in the treatment of aneurysms.
What outcomes have been reported in clinical studies?
Studies report successful support and navigability in endovascular coiling of cerebral aneurysms and successful treatment of ruptured lenticulostriate artery aneurysms.
What complications have been reported?
Reported complications include difficult catheterization due to acute angulation at the artery origin.
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.