Novoste Guiding Catheter

FDA-Cleared Indications

• Percutaneous catheter use for access to, navigation through, or delivery of devices within the vascular system, consistent with product code DQY.

Clinical Applications

• Use as a guiding catheter during selected percutaneous vascular interventions.
• Navigation through an arterial or venous access route to position another catheter or endovascular device.
• Use in procedures requiring fluoroscopic guidance and controlled catheter advancement.

Reported off-label uses

• Use as part of coronary brachytherapy procedures has been described for treatment of in-stent restenosis, but this use should be confirmed against the device-specific labeling and current availability.
• Use through transradial access has been reported in clinical practice for selected coronary interventions.

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

• Confirm the catheter's labeled size, length, tip configuration, guidewire compatibility, and maximum pressure before use.
• Use fluoroscopic imaging and standard sterile technique; advance without force to reduce the risk of vessel injury, dissection, or perforation.
• Compatibility with other catheters, wires, radiation-delivery systems, contrast agents, and access sheaths must be checked before the procedure.
• MRI safety depends on the exact model and whether the catheter contains metallic or other MR-conditional components; do not assume it is MRI safe without current manufacturer labeling.
• The device is generally intended for single-use procedural application; inspect packaging and device integrity before use and follow the labeled contraindications and warnings.