Vascon Neuropath Guiding Catheter

FDA-Cleared Indications

• Used in percutaneous vascular procedures to provide access and guidance for other intravascular devices.
• Intended for use by trained clinicians when vascular navigation and device delivery are required.
• The FDA classification and product code identify it as a percutaneous catheter; the available record does not provide a more specific disease or vessel indication.

Clinical Applications

• Providing catheter support and a working pathway during percutaneous vascular interventions.
• Guiding compatible diagnostic instruments through the vascular system.
• Supporting delivery of compatible therapeutic devices when vascular access and catheter stability are needed.
• Facilitating endovascular treatment of venous disease when the catheter is selected and used according to its labeling.

Reported off-label uses

• Use in selected complex endovascular procedures outside the catheter's specific labeling may occur in clinical practice, but safety and effectiveness depend on the anatomy, device specifications, and operator judgment.

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 available FDA record does not specify the complete range of catheter lengths, diameters, curves, or compatible guidewires; clinicians should verify the current product labeling before use.
• The catheter should be selected based on the target vessel, access route, anatomy, required support, and compatibility with the devices being delivered.
• Use requires fluoroscopic or other appropriate imaging guidance, sterile technique, and trained vascular-intervention personnel.
• MRI safety is not established by the information provided here. Confirm MR Safe, MR Conditional, or MR Unsafe status in the current manufacturer labeling before an MRI examination.
• Potential complications are those associated with percutaneous catheterization, including bleeding, infection, vessel injury, thrombosis, embolization, contrast reaction, and catheter malfunction.