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vena cava filter
Cook
Summary: The vena cava filter by Cook is a device used to prevent thromboembolism in high-risk patients. Key evidence highlights complications associated with retrieval and long-term use.
FDA Clearance Information
Pathway
510K
Number
K073528 ↗
Decision Date
February 27, 2008
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Cook vena cava filter was cleared by the FDA through the 510(k) pathway on February 27, 2008. It is classified as a Class 2 medical device.
What It Is
The vena cava filter is a medical device designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is primarily used in patients who cannot undergo anticoagulation therapy.
Clinical Applications
Commonly used in patients with deep venous thrombosis who have contraindications to anticoagulation, or in critically ill patients as a prophylactic measure. It is also used in cancer-associated thrombosis cases.
Evidence Summary
The literature includes a mix of systematic reviews, case series, and narrative reviews, with a total of 15 studies published up to 2024. These studies explore retrieval complications, long-term outcomes, and appropriateness of use.
Reported Outcomes
Published studies report that vena cava filters are effective in preventing thromboembolism in patients with contraindications to anticoagulation. However, retrieval rates are low, and long-term complications such as filter thrombosis and vena cava erosion have been noted.
Safety Profile
Reported complications include increased risk of mechanical issues such as embedded or tilted filters, erosion of the vena cava, and filter thrombosis. These complications can lead to venous hypertension and post-thrombotic syndrome.
Evidence Limitations
Evidence gaps include a need for more prospective studies on long-term outcomes and retrieval techniques. Current studies often have small sample sizes and lack uniformity in reporting complications.
Frequently Asked Questions
What are the clinical indications for vena cava filter?
Indicated for patients at risk of thromboembolism who cannot undergo anticoagulation therapy, such as those with deep venous thrombosis or cancer-associated thrombosis.
What outcomes have been reported in clinical studies?
Studies report effective prevention of thromboembolism but highlight low retrieval rates and long-term complications.
What complications have been reported?
Complications include embedded or tilted filters, erosion of the vena cava, and filter thrombosis, leading to potential venous hypertension and post-thrombotic syndrome.
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.