📊 Evidence-Based Reference
Gianturco-Roehm Bird S Nest Vena Cava Filter
Summary: The Gianturco-Roehm Bird's Nest Vena Cava Filter is a medical device used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. Key evidence includes studies on retrieval techniques and long-term outcomes.
FDA Clearance Information
Pathway ?
PMA
Number ?
P850049 ↗
Decision Date ?
September 14, 1999
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
0 studies
The Gianturco-Roehm Bird's Nest Vena Cava Filter was cleared by the FDA through the PMA pathway on September 14, 1999. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Gianturco-Roehm Bird's Nest Vena Cava Filter is designed to trap emboli (blood clots) in the inferior vena cava, preventing them from reaching the lungs. It is used in patients at risk of pulmonary embolism.
FDA-Cleared Indications
- Prevention of pulmonary embolism by trapping emboli in the inferior vena cava.
- Use in patients who cannot receive anticoagulation therapy.
- Use in patients with recurrent embolic events despite anticoagulation therapy.
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
- Protection from pulmonary embolism when anticoagulation is contraindicated.
- Protection from recurrent embolic events despite anticoagulation treatment.
- Use during an IVC filter placement procedure performed under imaging guidance.
Reported off-label uses
- Use in selected patients with severe trauma or a very high short-term risk of venous thromboembolism when standard prophylaxis is not possible; this is not a substitute for individualized clinical judgment or anticoagulation when appropriate.
- Use in selected patients with extensive iliocaval or lower-extremity thrombus when clinicians believe embolic risk is unusually high; evidence and appropriateness vary by case.
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
Available literature includes three studies ranging from 1990 to 2019, covering retrieval techniques and long-term outcomes. Study types include retrospective and prospective analyses.
Reported Outcomes
Published studies report that the Gianturco-Roehm Bird's Nest Vena Cava Filter is effective in preventing pulmonary embolism. Long-term follow-up studies indicate satisfactory clinical and radiographic outcomes.
Safety Profile
Reported complications include issues related to retrieval of the filter, as highlighted in a study using rigid endobronchial forceps. No specific adverse events are detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety data. Further research is needed to evaluate long-term safety and efficacy comprehensively.
Practical Considerations
- The device is a permanent-style vena cava filter and should not be assumed to be routinely retrievable; removal depends on the specific device, anatomy, implantation circumstances and procedural feasibility.
- Placement requires suitable inferior vena cava anatomy and imaging evaluation for thrombus, vessel size, renal function and access planning.
- The filter is delivered through a vascular access sheath, commonly through the jugular or femoral vein, with fluoroscopic guidance.
- MRI conditions and compatibility should be verified in the current manufacturer labeling and institutional device records before scanning; do not assume MRI safety from the filter name alone.
- Potential complications include access-site bleeding, filter migration or tilt, inferior vena cava perforation or thrombosis, recurrent pulmonary embolism and difficult retrieval or removal.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Gianturco-Roehm Bird's Nest Vena Cava Filter?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism with satisfactory long-term outcomes.
What complications have been reported?
Complications related to retrieval have been reported, but specific adverse events are not detailed in the provided studies.
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.