Gliderxtreme PTA Balloon Catheter Cb Over the Wire 0 014 0 018 Guide Wire

FDA-Cleared Indications

• Treatment of stenosis within venous stents using percutaneous transluminal angioplasty.

Clinical Applications

• Balloon angioplasty of narrowed venous stents.
• Treatment of reduced blood flow caused by stenosis within an implanted venous stent.
• Use during endovascular venous-stent procedures when balloon expansion or remodeling is required.

Reported off-label uses

• Balloon angioplasty of selected non-stented venous stenoses may be performed in clinical practice with compatible balloon catheters, but this specific use is outside the stated FDA indication for this device.
• Use in arterial angioplasty may be considered for some balloon catheters of this type, but it is off-label for the stated GliderXtreme indication and must follow applicable labeling and clinical 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 catheter is designed for over-the-wire use with 0.014-inch or 0.018-inch guidewires.
• Balloon diameter and length should be selected to match the target vessel and stent dimensions; excessive sizing or inflation can cause vessel or stent injury.
• The procedure requires fluoroscopic or other appropriate imaging guidance, vascular access, and clinicians trained in endovascular angioplasty.
• Review the current device labeling for balloon inflation limits, compatibility, preparation, and contraindications before use.
• MRI safety depends on the complete device configuration and labeling; do not assume the catheter or any retained component is MRI safe without checking the manufacturer’s current instructions.