Psg Tm Edm Tm Infusion Catheter

FDA-Cleared Indications

• Infusion of therapeutic agents into the venous system.
• Percutaneous catheter access to blood vessels for delivery of fluids, medications, or contrast media, consistent with the device labeling and product code.

Clinical Applications

• Venous infusion of medications or other therapeutic agents.
• Delivery of contrast media during vascular imaging procedures.
• Catheter-based venous procedures requiring controlled infusion through percutaneous vascular access.

Reported off-label uses

• Catheter-directed thrombolytic infusion for selected venous thrombosis cases.
• Regional chemotherapy infusion in selected oncology procedures.

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 catheter sizes, lengths, infusion limits, and connector configuration should be confirmed in the manufacturer’s labeling before use.
• Placement generally requires sterile technique and fluoroscopic or other appropriate imaging guidance through a venous access site.
• Use only with compatible infusion pumps, tubing, syringes, and connectors; verify pressure and flow limits before infusion.
• MRI safety is not established from the information provided. Confirm the exact device model and manufacturer labeling before an MRI examination.
• Potential complications include bleeding, infection, venous injury, thrombosis, air embolism, malposition, and medication-related adverse effects. Contraindications and precautions depend on the intended infusion and the patient’s vascular condition.