Rubicon Support Catheter

FDA-Cleared Indications

• For percutaneous vascular procedures in which a catheter is used to support or guide a guidewire.
• For use in the peripheral vasculature when guidewire support is needed during an endovascular intervention.

Clinical Applications

• Supporting and directing guidewires during percutaneous peripheral vascular procedures.
• Providing catheter support while accessing difficult or tortuous peripheral vascular anatomy.
• Helping facilitate advancement of interventional devices after guidewire access has been established.

Reported off-label uses

• Use as an adjunct catheter during venous recanalization or chronic venous occlusion procedures may occur in clinical practice, but the specific application should be confirmed against the current device labeling.

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 is available in different sizes and configurations; the appropriate option depends on vessel size, access route, target anatomy, and the guidewire being used.
• Confirm guidewire and accessory-device compatibility before use, and follow the current manufacturer instructions for use.
• Advance and manipulate the catheter under appropriate fluoroscopic or other intravascular imaging guidance to reduce the risk of vessel injury.
• MRI safety depends on the exact model and components; consult the current Boston Scientific labeling before an MRI examination.
• Contraindications, warnings, and restrictions should be checked in the current instructions for use. The device is intended for use by trained clinicians in appropriate vascular procedures.