📋 FDA Reference
Lifeline Tle 484-02
Intermedics
Summary: The Lifeline TLE 484-02 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by trapping blood clots. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K843394 ↗
Decision Date ?
September 24, 1984
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Lifeline TLE 484-02 was cleared through the FDA 510k pathway on September 24, 1984. Manufactured by Intermedics, it is a Class III device under product code DTB.
What It Is
The Lifeline TLE 484-02 is an IVC filter designed to prevent blood clots from traveling to the lungs, which can cause a pulmonary embolism. It is implanted in the inferior vena cava, the large vein that carries blood from the lower body to the heart. The filter catches clots while allowing normal blood flow, providing a protective measure for patients at risk of thromboembolic events.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients with venous thromboembolism.
- Use when anticoagulation is contraindicated, cannot be used, or has failed.
- Protection from embolization of thrombi traveling through the inferior vena cava to the pulmonary arteries.
Clinical Applications
- Placement in the inferior vena cava to prevent lower-extremity or pelvic venous clots from reaching the lungs.
- Treatment of selected patients with deep vein thrombosis who cannot receive anticoagulants.
- Use in patients with pulmonary embolism risk despite anticoagulant therapy.
- Fluoroscopic IVC filter placement performed by an interventional radiologist or vascular surgeon.
Reported off-label uses
- Temporary pulmonary embolism protection during selected high-risk trauma or major surgical situations when anticoagulation is not possible.
- Protection in patients with recurrent venous thromboembolism 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.
Practical Considerations
- The filter must be appropriately sized for the diameter and anatomy of the inferior vena cava; available sizes and deployment specifications should be confirmed from the original device labeling.
- Placement requires venous access and imaging guidance, typically fluoroscopy, to identify the IVC and confirm filter position.
- The device is an older IVC filter, so current clinicians should verify whether it is available, compatible with present-day delivery systems, and supported by current labeling.
- MRI safety should not be assumed from the device name or FDA classification. Confirm the original labeling or obtain a formal device-specific MRI safety assessment before scanning.
- Potential complications include access-site bleeding, malposition, caval perforation, filter thrombosis, migration, fracture, and recurrent pulmonary embolism. Anticoagulation remains appropriate when it is safe and indicated.
Procedures that use this device
Frequently Asked Questions
What is Lifeline TLE 484-02 used for?
It is used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiology and vascular surgery specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation is not an option.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.