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carotid guiding sheath
Terumo Medical
Summary: The carotid guiding sheath by Terumo Medical is used primarily for neurointerventional procedures. Key evidence highlights its use in challenging anatomical scenarios.
FDA Clearance Information
Pathway
510K
Number
K012812 ↗
Decision Date
November 14, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The carotid guiding sheath was cleared by the FDA via the 510(k) pathway on November 14, 2001. It is manufactured by Terumo Medical and classified as a Class 2 device.
What It Is
The carotid guiding sheath is a medical device used to facilitate access to the carotid arteries during neurointerventional procedures. It is designed to provide support and stability for catheters and other devices during vascular interventions.
Clinical Applications
Commonly used in procedures such as carotid artery stenting and embolization, the sheath is particularly useful in patients with challenging vascular anatomy, such as tortuous arteries or anatomical variants.
Evidence Summary
The literature includes 10 studies, with types ranging from case series to other observational designs, published between 2023 and 2025. These studies explore various techniques and outcomes associated with the use of the carotid guiding sheath.
Reported Outcomes
Published studies report successful navigation and stabilization of the guiding sheath in complex vascular anatomies, such as in patients with aberrant right subclavian arteries. Techniques like the turn-over method have been highlighted for improving procedural success.
Safety Profile
Reported complications include challenges in sheath insertion due to severe atherosclerosis or tortuous arteries. However, specific adverse events related to the sheath itself are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of randomized controlled trials. Further research is needed to establish long-term outcomes and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the carotid guiding sheath?
The carotid guiding sheath is indicated for use in neurointerventional procedures requiring access to the carotid arteries, particularly in cases with challenging vascular anatomy.
What outcomes have been reported in clinical studies?
Studies have reported successful sheath navigation and stabilization in complex anatomical scenarios, with techniques like the turn-over method enhancing procedural success.
What complications have been reported?
Reported complications include difficulties in sheath insertion due to severe atherosclerosis or tortuous arteries, but specific adverse events are not detailed in the studies.
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.