Atrium Medical Corporation Clearway RX Catheter

FDA-Cleared Indications

• Percutaneous catheter use in the vascular system, as classified under FDA product code DQY and 21 CFR 870.1250.
• The specific FDA-cleared indication cannot be stated from the available record because the FDA indication field is listed only as “Statement.”

Clinical Applications

• Catheter-based delivery of a therapeutic agent to a selected vascular location when consistent with the device's complete FDA labeling.
• Use during an image-guided endovascular procedure in which local treatment of a vascular lesion is required and the catheter's labeled compatibility requirements are met.

Reported off-label uses

• Local delivery of thrombolytic medication during selected catheter-directed treatment of deep vein thrombosis or other venous thrombosis.
• Adjunctive local drug delivery during selected venous interventions, including treatment associated with venous stenting.

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 exact catheter diameter, working length, guidewire requirements, and drug-compatibility limits should be confirmed in the current instructions for use; these specifications are not provided in the FDA summary.
• Use requires vascular access and fluoroscopic or other appropriate imaging guidance by a trained clinician.
• The treating team should verify compatibility with the intended guidewire, sheath, contrast agent, therapeutic medication, and vascular anatomy before use.
• MRI safety or conditional labeling is not established in the information provided; review the current labeling before MRI.
• Potential risks are those associated with vascular catheterization and local drug delivery, including bleeding, vascular injury, thrombosis, embolization, infection, allergic reaction, and medication-related complications.