Maxim Pf Models 033-581 033-590

FDA-Cleared Indications

• Prevention of pulmonary embolism in patients with deep vein thrombosis who cannot be treated with anticoagulants.
• Prevention of recurrent pulmonary embolism in patients who develop embolism despite anticoagulant therapy.

Clinical Applications

• Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
• Use in patients with deep vein thrombosis who have a contraindication to anticoagulation.
• Use in patients with recurrent pulmonary embolism despite appropriate anticoagulant therapy.
• Fluoroscopic placement by an interventional radiologist or vascular surgeon in a hospital or procedural setting.

Reported off-label uses

• Temporary protection from pulmonary embolism in selected patients with a short-term contraindication to anticoagulation.
• Pulmonary embolism prevention in selected patients with high venous thromboembolism risk when anticoagulation is not feasible, outside the specific labeled indications.

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 models are available in different sizes; the appropriate size depends on the patient's inferior vena cava anatomy and the device labeling.
• Placement requires venous access and fluoroscopic imaging to position the filter in the inferior vena cava.
• The operator should review the patient's venous anatomy, thrombus location, and compatibility with other vascular devices before placement.
• The available FDA record does not establish MRI safety; MRI conditions should be confirmed from the current device labeling or manufacturer information before scanning.
• Anticoagulation remains the standard treatment for venous thromboembolism when it is safe. Filter placement has procedural risks and does not treat the underlying clot.