Headway 21 Microcatheter Model MC212150S

FDA-Cleared Indications

• Used for the delivery of therapeutic agents or devices within the neurovascular system.
• Intended for percutaneous catheter-based access and treatment of abnormalities in the cerebral vasculature.

Clinical Applications

• Delivery of embolic agents during endovascular treatment of cerebral vascular abnormalities.
• Delivery of therapeutic devices used in neurovascular procedures, when compatible with the catheter and labeled for that use.
• Navigation through tortuous cerebral blood vessels to position treatment materials at a targeted location.

Reported off-label uses

• Use in selected neurovascular procedures not specifically described in the device labeling, based on operator experience and available clinical evidence.

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.

Practical Considerations

• The MC212150S model is a 21-size microcatheter; clinicians should confirm its inner diameter, usable length, distal configuration and compatibility with the intended guidewire, embolic agent or therapeutic device.
• The catheter is advanced through a guide catheter or other appropriate access system under fluoroscopic or other intravascular imaging guidance.
• Careful handling is required because excessive force, sharp bending or resistance can damage the catheter or vessel.
• MRI safety depends on the exact device configuration and whether the catheter remains in the patient; the current manufacturer labeling should be reviewed before MRI.
• Contraindications, warnings and compatibility requirements in the current instructions for use should be checked before each procedure.