đź“Š Evidence-Based Reference
arc intracranial support catheter arc mini intracranial support catheter
Micro Therapeutics Inc Dba Ev3 Neurovascular
Summary: The arc intracranial support catheter is used in endovascular procedures for acute ischemic stroke. Key evidence highlights its role in mechanical thrombectomy for large vessel occlusion.
FDA Clearance Information
Pathway
510K
Number
K150107 ↗
Decision Date
July 29, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The arc intracranial support catheter was cleared by the FDA via the 510(k) pathway on July 29, 2015. It is manufactured by Micro Therapeutics Inc, classified as a Class 2 device.
What It Is
The arc intracranial support catheter is designed for use in neurovascular procedures, particularly in providing support during endovascular interventions for acute ischemic stroke. It aids in the navigation and stability of other devices within the cerebral vasculature.
Clinical Applications
Commonly used in the management of acute ischemic stroke due to large vessel occlusion, the catheter facilitates mechanical thrombectomy procedures. It is particularly relevant in cases where rapid revascularization is critical.
Evidence Summary
The available literature includes a systematic review and meta-analysis, a technical report, and a study on drug delivery systems, with publication years ranging from 2014 to 2025. These studies explore various aspects of endovascular interventions.
Reported Outcomes
Published studies report that the arc intracranial support catheter is effective in facilitating mechanical thrombectomy in acute ischemic stroke. The device is noted for its role in improving procedural success rates in large vessel occlusion cases.
Safety Profile
Reported complications include challenges in device navigation and potential vessel trauma during procedures. However, specific adverse events related to the catheter itself are not extensively documented in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the catheter's performance. 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 arc intracranial support catheter?
The arc intracranial support catheter is indicated for use in endovascular procedures, particularly in the management of acute ischemic stroke due to large vessel occlusion.
What outcomes have been reported in clinical studies?
Clinical studies have reported that the catheter is effective in facilitating mechanical thrombectomy, improving procedural success rates in large vessel occlusion cases.
What complications have been reported?
Reported complications include potential vessel trauma and challenges in device navigation, although specific adverse events are not extensively documented.
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.