Px 53 15-bp Model 130 050 and Px 60 15-bp Model 130 051

FDA-Cleared Indications

• Prevention of pulmonary embolism in patients at risk for venous thromboembolism.
• Use in patients for whom anticoagulation is contraindicated or not appropriate.
• Use when pulmonary embolism risk persists despite anticoagulation therapy.

Clinical Applications

• Placement in the inferior vena cava for mechanical pulmonary embolism protection.
• Treatment of patients with deep vein thrombosis who cannot receive anticoagulant medication.
• Protection from pulmonary embolism in selected patients with recurrent venous thromboembolism despite anticoagulation.
• Placement during an image-guided IVC filter procedure by interventional radiology or vascular surgery teams.

Reported off-label uses

• Temporary pulmonary embolism protection during selected high-risk trauma or surgical situations when anticoagulation cannot be used.
• Prophylactic placement in patients considered at exceptionally high risk for venous thromboembolism without a current pulmonary embolism.

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 px 53 and px 60 models are different size configurations intended to accommodate variations in inferior vena cava diameter; the treating clinician selects the appropriate model and delivery system.
• Placement requires venous access, commonly through the femoral vein in the groin or the internal jugular vein in the neck, with fluoroscopic imaging to confirm IVC anatomy and filter position.
• The record identifies these devices as IVC filters, but the supplied information does not establish whether they are retrievable or provide specific MRI-conditional labeling. MRI compatibility should be confirmed in the original FDA labeling or manufacturer instructions before scanning.
• Contraindications, anticoagulation status, IVC anatomy, thrombus in the intended landing zone, and the risk of filter migration, tilt, perforation, fracture, or caval thrombosis should be assessed before placement.
• The supplied record lists FDA 510(k) K000763, dated April 6, 2000, product code DTB, and Class III classification. Current labeling and device availability should be verified before clinical use.