Angiosculpt RX Ptca Scoring Balloon Catheter Angiosculpt Evo RX Ptca Scoring Balloon Catheter with Hydrophilic Coating

FDA-Cleared Indications

• Alternate supplier for a catheter component under PMA P050018.
• Use is limited to the specific catheter component configuration and labeling reviewed by the FDA.

Clinical Applications

• Use as a labeled component of a PTCA catheter system.
• Use during coronary angioplasty when the complete catheter system is used according to its FDA-approved labeling.

Reported off-label uses

• Scoring-balloon angioplasty for plaque modification before coronary stent placement is a recognized use of this device category, but it should not be assumed to be FDA-approved for this specific record unless stated in the current labeling.
• Use in peripheral arteries is reported for some scoring-balloon catheter platforms, but should not be performed with this device unless specifically authorized by its 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 FDA record describes this product as an alternate supplier for a catheter component; confirm compatibility with the complete catheter system and the current manufacturer instructions for use.
• Available diameter and working-length options depend on the specific catheter configuration. Match the selected size to the target vessel and lesion according to labeling.
• The catheter is used over a compatible coronary guidewire under fluoroscopic imaging, generally through arterial access such as the radial or femoral artery.
• The hydrophilic coating may improve tracking, but the catheter must be handled according to the instructions for use to avoid coating damage or loss of device performance.
• MRI safety, contraindications, balloon-pressure limits, and other device-specific restrictions should be verified in the current labeling; do not assume MR safety from the coating or catheter design alone.