Vena Cava Filter
Vena-Tech
FDA Clearance Information
The Vena-Tech vena cava filter was cleared by the FDA via the 510k pathway on March 10, 1989. It is manufactured by Vena-Tech and classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- Prevention of pulmonary embolism by filtering thrombi from the venous circulation.
- Use in patients at risk for pulmonary embolism when anticoagulant therapy is contraindicated.
Clinical Applications
- Placement in the inferior vena cava for protection against pulmonary embolism.
- Use in patients with venous thromboembolism who cannot receive anticoagulant medication.
- Use when protection from embolization is clinically needed during management of thromboembolic disease.
Reported off-label uses
- Temporary protection from pulmonary embolism in selected trauma or critically ill patients when anticoagulation is not possible.
- Use in selected patients with recurrent pulmonary embolism despite therapeutic anticoagulation.
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.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The filter is intended for placement in the inferior vena cava and requires appropriate vessel imaging and sizing before deployment.
- Access is commonly obtained through a femoral or internal jugular vein, with fluoroscopic or other imaging guidance.
- The original Vena-Tech filter is generally considered a permanent filter; retrieval should not be assumed unless the specific device labeling and clinical assessment support it.
- Long-term risks can include filter thrombosis, migration, penetration of the vena cava wall, fracture, and recurrent deep vein thrombosis.
- MRI conditions should be confirmed from the device-specific labeling and the current institutional MRI safety policy before scanning.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for vena cava filter?
Indications include prevention of pulmonary embolism in patients with contraindications to anticoagulation, and prophylactic use in high-risk trauma or critically ill patients.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, but highlight increased complications with longer filter dwell times.
What complications have been reported?
Safety data indicate complications such as filter migration, tilt, thrombosis, and long-term caval erosion, with increased retrieval difficulties over time.