Novacross Microcatheter

FDA-Cleared Indications

• Used to facilitate the placement and advancement of guidewires during percutaneous coronary interventions.
• Intended for use in the coronary vasculature in procedures requiring catheter-based access and guidewire support.
• Cleared as a percutaneous catheter under FDA product code DQY.

Clinical Applications

• Supporting guidewire passage through complex coronary artery lesions.
• Facilitating catheter-based treatment of coronary chronic total occlusions when used according to the device labeling.
• Providing microcatheter support during percutaneous coronary intervention.

Reported off-label uses

• Use in selected peripheral vascular interventions may occur in clinical practice, but this is outside the coronary indication and should not be assumed to be FDA-cleared for this device.

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 catheter must be used with guidewires, guide catheters and other accessories that are compatible with the specific device size and labeling.
• Advancement should be performed under appropriate fluoroscopic imaging by trained operators; resistance should not be overcome with excessive force.
• The device is generally intended for single use and should not be resterilized or reused unless the labeling specifically permits it.
• MRI safety depends on the exact model and labeling; confirm MR Safe, MR Conditional or MR Unsafe status before an MRI examination.
• Contraindications, vessel size limitations, maximum pressure ratings and other technical specifications should be checked in the current manufacturer instructions for use.