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gianturco-roehm birds nest vena cava filter
Cook
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
510K
Number
K161218 ↗
Decision Date
July 22, 2016
Product Code
DTK
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.
Clinical Applications
This device is commonly used in patients with contraindications to anticoagulation or those who have experienced recurrent venous thromboembolism despite anticoagulation. It is typically placed in the inferior vena cava via a minimally invasive procedure.
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.
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.