Cordis Trapease Permanent Vena Cava Filter and Introduction Kit

FDA-Cleared Indications

• Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
• Use in patients with pulmonary thromboembolism when anticoagulation is contraindicated.
• Use in patients with pulmonary thromboembolism in whom anticoagulant therapy has failed.

Clinical Applications

• Permanent inferior vena cava filter placement for selected patients with venous thromboembolism.
• Pulmonary embolism prevention when anticoagulant medication cannot be used because of bleeding risk or another contraindication.
• Pulmonary embolism prevention when embolic events recur despite appropriate anticoagulant therapy.

Reported off-label uses

• Temporary protection from pulmonary embolism during a period of exceptionally high clot risk when anticoagulation is temporarily unsuitable; permanent implantation may be inappropriate if retrieval is not planned or possible.
• Prophylactic placement in selected patients without documented venous thromboembolism but with perceived high risk of pulmonary embolism; evidence and appropriateness vary by patient.

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 TrapEase filter is intended for permanent implantation and is not a routine retrieval filter; clinicians should confirm that a permanent implant is appropriate before placement.
• Placement is usually performed through femoral or internal jugular venous access under fluoroscopic imaging, with filter sizing and positioning based on inferior vena cava anatomy.
• Potential complications include access-site bleeding, filter migration or tilt, inferior vena cava thrombosis or perforation, recurrent pulmonary embolism, and filter fracture; anticoagulation does not necessarily eliminate the need for follow-up.
• MRI conditions and compatibility should be confirmed in the current Cordis labeling and facility MRI policy before scanning, including field strength and device-specific conditions.
• The filter does not treat the underlying clot. When safe and appropriate, anticoagulation remains an important treatment for venous thromboembolism, and contraindications to anticoagulation should be reassessed.