Neuron Delivery Catheter 070

FDA-Cleared Indications

• Delivery of therapeutic agents into the vascular system.
• Delivery of therapeutic devices into the vascular system.
• Use in percutaneous vascular procedures when catheter-based delivery is required.

Clinical Applications

• Catheter-based delivery of therapeutic devices during vascular interventions.
• Catheter-based delivery of therapeutic agents into selected blood vessels.
• Use by specialists during procedures requiring navigation through complex vascular anatomy.

Reported off-label uses

• Use as an access or support catheter during selected venous interventions when the treating physician determines that its characteristics are appropriate.

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

• Available sizes and configuration should be matched to the target vessel, access route, anatomy and intended device or agent.
• Compatibility with guidewires, delivery systems and therapeutic devices must be confirmed before use.
• The catheter should be advanced under appropriate imaging guidance by clinicians trained in percutaneous vascular procedures.
• MRI safety and conditional-use information must be checked in the current manufacturer instructions for use; the FDA clearance alone does not establish MRI compatibility.
• Contraindications, warnings, vessel-injury risks and handling instructions are described in the current manufacturer labeling and should be reviewed before the procedure.