Arc Intracranial Support Catheter Arc Mini Intracranial Support Catheter
Micro Therapeutics Inc Dba Ev3 Neurovascular
Product: ArcTM — all models and sizes
FDA Clearance Information
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
FDA-Cleared Indications
- Percutaneous catheter use in endovascular procedures involving the cerebral vasculature.
- Use as an intracranial support catheter to assist with the delivery, positioning, or stabilization of other devices during neurovascular intervention.
Clinical Applications
- Providing support during catheter-based neurovascular procedures.
- Supporting the navigation and positioning of interventional devices within cerebral blood vessels.
- Assisting endovascular treatment procedures in which stable intracranial catheter support is required.
Reported off-label uses
- Use as an adjunct during mechanical thrombectomy for selected acute ischemic strokes may be described in clinical practice, but the supplied FDA record does not provide detailed stroke-specific labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The record identifies arc and arc mini versions; exact catheter diameter, usable length, and compatibility specifications should be confirmed in the current manufacturer instructions for use.
- The catheter is intended for percutaneous endovascular use and is typically manipulated under fluoroscopic or other compatible angiographic imaging.
- Compatibility with guidewires, microcatheters, aspiration systems, and other devices must be checked before use.
- MRI safety and conditional-use requirements are not provided in the supplied record; consult the current labeling before MRI.
- Contraindications, warnings, and handling requirements should be reviewed in the manufacturer’s current instructions for use.
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.