PTA and Ptv

FDA-Cleared Indications

• Percutaneous catheter use in the diagnosis or treatment of blood-vessel disease.
• Use during image-guided vascular interventions when percutaneous catheter access or delivery is required.

Clinical Applications

• Catheter-based vascular procedures performed through percutaneous access.
• Image-guided evaluation or treatment of peripheral blood vessels.
• Catheter delivery during interventional radiology or vascular procedures, when compatible with the specific device configuration.

Reported off-label uses

• Use in venous interventions such as iliac or central-vein procedures may occur in clinical practice, but the available FDA record does not provide enough labeling detail to confirm a specific venous indication for PTA and PTV.

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 available record does not identify the device's full size range, working length, balloon or catheter configuration, or required guidewire and introducer compatibility; these details should be confirmed in the current manufacturer instructions for use.
• Use requires fluoroscopic or other appropriate imaging guidance and trained vascular-intervention personnel.
• Contraindications, vessel-size requirements, contrast compatibility, and handling instructions should be taken from the device-specific labeling.
• MRI safety cannot be determined from the available FDA summary. Confirm the current labeling before MRI, including whether the device is MR Safe, MR Conditional, or not evaluated for MRI.
• Potential procedural risks include bleeding or hematoma at the access site, vessel injury, thrombosis, embolization, infection, contrast reaction, and failure to achieve the intended result.