Stingray Orienting Balloon Catheter

FDA-Cleared Indications

• Use as a percutaneous catheter in vascular procedures, consistent with the FDA classification for this device category.
• Use according to the cleared device labeling and instructions for use for catheter positioning or orientation.

Clinical Applications

• Catheter orientation during selected vascular interventions.
• Balloon-assisted catheter positioning within a blood vessel.
• Use during procedures in which controlled catheter positioning is needed.

Reported off-label uses

• Use to assist with positioning during venous stent procedures has been described for balloon-orienting catheter devices, but this application should be confirmed against the current device labeling and institutional policy.

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, working length, balloon dimensions and guidewire compatibility must be confirmed in the current instructions for use.
• The catheter should be selected for the target vessel and handled under fluoroscopic or other appropriate imaging guidance.
• Do not inflate the balloon beyond the labeled pressure or use it in a vessel that is too small for the selected balloon.
• MRI safety or conditional status is not established in the supplied FDA record; check the current labeling before MRI.
• Contraindications, warnings and compatibility with stents or delivery systems should be reviewed in the current manufacturer instructions for use.