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Gianturco-Roehm Birds Nest Vena Cava Filter
Summary: The Gianturco-Roehm Bird's Nest Vena Cava Filter is a medical device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence includes studies on retrieval techniques and long-term outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K161218 ↗
Decision Date ?
July 22, 2016
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 510(k) pathway on July 22, 2016. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Gianturco-Roehm Bird's Nest Vena Cava Filter is designed to trap emboli in the inferior vena cava, preventing them from reaching the lungs. It is used in patients at risk for pulmonary embolism who cannot undergo anticoagulation therapy.
FDA-Cleared Indications
- Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
- Use in patients with venous thromboembolism who have a contraindication to anticoagulation.
- Use when recurrent pulmonary embolism or venous thromboembolism occurs despite anticoagulant therapy.
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
- Protection from pulmonary embolism in patients who cannot receive anticoagulant medication.
- Protection from recurrent embolism when anticoagulation has not adequately prevented thromboembolism.
- Percutaneous IVC filter placement using fluoroscopic or other appropriate imaging guidance.
Reported off-label uses
- Use for selected patients with a high risk of pulmonary embolism when anticoagulation is possible but considered inadequate or unusually hazardous.
- Use for temporary protection during selected high-risk procedures in patients without an absolute contraindication to 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
The literature includes three studies ranging from 1990 to 2019, covering various aspects such as retrieval techniques and long-term outcomes. Study types include retrospective and prospective analyses.
Reported Outcomes
Published studies report on the successful retrieval of the filter using rigid endobronchial forceps and long-term clinical outcomes post-insertion. The studies highlight the device's efficacy in preventing pulmonary embolism over extended periods.
Safety Profile
Reported complications include difficulties in retrieval and potential for filter migration. However, specific adverse event rates are not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety outcomes. Further research is needed to evaluate long-term safety and efficacy comprehensively.
Practical Considerations
- The Bird's Nest filter is a permanent IVC filter design; retrieval is technically possible in selected cases but is not its typical intended use and may be difficult.
- It is delivered through a catheter and positioned in the inferior vena cava under imaging guidance, commonly through femoral or jugular venous access.
- The filter's wire-basket design is intended to accommodate a range of IVC diameters, but preprocedure imaging is needed to assess anatomy, thrombus, vessel size, and access.
- MRI safety and conditions depend on the exact device labeling and scanner parameters; the implant card and current manufacturer instructions should be checked before MRI.
- Potential complications include access-site bleeding, filter migration or tilt, IVC perforation, thrombosis or occlusion, recurrent pulmonary embolism, and difficulty with later 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 who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report successful prevention of pulmonary embolism and effective retrieval of the filter.
What complications have been reported?
Reported complications include retrieval difficulties and potential filter migration.
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.