Trapease Permanent Vena Cava Filter and Introduction Kit Model 466-p306a

FDA-Cleared Indications

• Prevention of pulmonary embolism by trapping thromboemboli in the inferior vena cava.
• Use in patients at risk for thromboembolic disease when anticoagulation is contraindicated, ineffective, or not appropriate.

Clinical Applications

• Permanent inferior vena cava filter placement for mechanical protection against pulmonary embolism.
• Treatment of patients who cannot receive anticoagulation because of bleeding risk or another contraindication.
• Protection from recurrent pulmonary embolism or thromboembolic events when anticoagulation has not provided adequate protection.

Reported off-label uses

• Temporary protection during selected high-risk periods when a retrievable filter would ordinarily be considered but is unavailable or unsuitable.
• Prophylactic placement in selected patients without documented venous thromboembolism who are considered at unusually high risk for 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

• This is a permanent filter; removal is not the intended use and may be difficult or clinically inappropriate after implantation.
• Placement is generally performed through venous access, commonly the internal jugular or femoral vein, using fluoroscopic or other image guidance.
• The filter and delivery system must be matched to the labeled inferior vena cava diameter and access requirements; the model-specific instructions for use should be checked before implantation.
• MRI conditions, including field strength and scanning limits, should be confirmed in the current manufacturer labeling and institutional MRI policy before imaging.
• The device does not treat an existing deep vein thrombosis or pulmonary embolism. Anticoagulation, when safe and clinically indicated, and other treatments may still be needed.