đź“Š Evidence-Based Reference
gianturco-roehm bird s 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 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
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.
Clinical Applications
This device is commonly used in patients who have contraindications to anticoagulation therapy or have experienced recurrent embolic events despite anticoagulation. It is placed in the inferior vena cava to prevent pulmonary embolism.
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.
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.