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cerenovus large bore catheter
Codman & Shurtleff
Summary: The Cerenovus Large Bore Catheter by Codman & Shurtleff is used primarily in mechanical thrombectomy for large vessel occlusions. Key evidence highlights its role in rapid recanalization, though safety and efficacy in randomized trials remain under investigation.
FDA Clearance Information
Pathway
510K
Number
K191237 ↗
Decision Date
November 8, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cerenovus Large Bore Catheter was cleared by the FDA via the 510(k) pathway on November 8, 2019. It is manufactured by Codman & Shurtleff and classified as a Class 2 device.
What It Is
The Cerenovus Large Bore Catheter is designed for neuroendovascular procedures, particularly mechanical thrombectomy in large vessel occlusions. It facilitates rapid and effective recanalization by providing robust intracranial access.
Clinical Applications
Commonly used in the treatment of acute ischemic stroke due to large vessel occlusions, the catheter is employed in scenarios requiring efficient clot retrieval and vessel recanalization. It is also used in delivering large intracranial devices.
Evidence Summary
The literature includes 11 studies, comprising randomized controlled trials, case series, and retrospective analyses, published between 2024 and 2025. These studies explore the catheter's efficacy and safety in neurovascular interventions.
Reported Outcomes
Published studies report that the Cerenovus Large Bore Catheter is effective in achieving rapid recanalization in large vessel occlusion cases. Initial multicenter experiences suggest its utility in mechanical thrombectomy, though comprehensive efficacy data from randomized trials are still emerging.
Safety Profile
Reported complications include potential risks associated with large bore catheter use, such as vessel injury and thrombus formation. However, detailed safety profiles are not extensively covered in the available studies.
Evidence Limitations
The current evidence is limited by the lack of extensive randomized controlled trials specifically evaluating the Cerenovus Large Bore Catheter. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for Cerenovus Large Bore Catheter?
The catheter is indicated for use in mechanical thrombectomy for large vessel occlusions, particularly in acute ischemic stroke management.
What outcomes have been reported in clinical studies?
Studies report effective recanalization in large vessel occlusions, with initial experiences indicating its utility in mechanical thrombectomy.
What complications have been reported?
Reported complications include risks of vessel injury and thrombus formation, though comprehensive safety data are limited.
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.