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destination carotid guiding sheath
Terumo Medical
Summary: The destination carotid guiding sheath by Terumo Medical is a device used primarily in endovascular procedures for carotid artery access. Key evidence includes studies on its use in stroke thrombectomy and chronic carotid artery occlusion.
FDA Clearance Information
Pathway
510K
Number
K052185 ↗
Decision Date
September 6, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The destination carotid guiding sheath was cleared by the FDA via the 510(k) pathway on September 6, 2005. It is manufactured by Terumo Medical and classified as a Class 2 device under product code DYB.
What It Is
The destination carotid guiding sheath is a medical device designed to provide stable access to the carotid artery during endovascular procedures. It facilitates the delivery of therapeutic devices to the target site, aiding in interventions such as embolization.
Clinical Applications
This device is commonly used in procedures requiring carotid artery access, such as stroke thrombectomy and treatment of carotid artery occlusions. It is particularly useful in scenarios where precise and stable catheter positioning is critical.
Evidence Summary
The available literature includes four studies, focusing on its use in stroke thrombectomy and carotid artery occlusion. These studies are registered on ClinicalTrials.gov, though specific outcomes and safety data are not detailed.
Reported Outcomes
Published studies report the use of the destination carotid guiding sheath in optimizing outcomes for stroke thrombectomy and revascularization procedures. However, specific efficacy data from these studies are not provided in the available summaries.
Safety Profile
Reported complications include general risks associated with endovascular procedures, such as vascular injury or device-related complications. Specific safety data from the studies are not detailed in the provided summaries.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available study summaries. Further research is needed to provide comprehensive efficacy and safety profiles, as well as to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for destination carotid guiding sheath?
The device is indicated for use in endovascular procedures requiring carotid artery access, such as stroke thrombectomy and treatment of carotid artery occlusions.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the available study summaries, but the device is used to optimize procedural success in stroke thrombectomy and revascularization.
What complications have been reported?
Reported complications include general risks of endovascular procedures, though specific adverse events are not detailed in the available evidence.
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.