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vena cava filter
Vena-Tech
Summary: The Vena-Tech vena cava filter is a device used to prevent thromboembolism in high-risk patients. It is primarily used when anticoagulation is contraindicated. Key evidence highlights complications associated with retrieval and long-term use.
FDA Clearance Information
Pathway 510K
Number K901454 ↗
Decision Date May 29, 1991
Product Code DTK
Device Class Class 2
Evidence 0 studies
The Vena-Tech vena cava filter was cleared by the FDA through the 510k pathway on May 29, 1991. It is manufactured by Vena-Tech and classified as a Class 2 medical device.
What It Is
The vena cava filter is a medical device implanted into the inferior vena cava to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients at high risk of thromboembolism, particularly when anticoagulation therapy is not suitable.
Clinical Applications
Commonly used in patients with deep venous thrombosis who cannot undergo anticoagulation, the vena cava filter is also deployed prophylactically in trauma and critically ill patients. It serves as an alternative in cancer-associated thrombosis when anticoagulation is contraindicated.
Evidence Summary
The literature includes 15 studies, comprising systematic reviews, case series, and narrative reviews, published up to 2024. These studies explore complications, retrieval techniques, and clinical guidelines for vena cava filter use.
Reported Outcomes
Published studies report that vena cava filters effectively prevent thromboembolism in high-risk patients. However, there is a noted increase in complications with prolonged filter dwell time. The filters are particularly beneficial in patients with contraindications to anticoagulation.
Safety Profile
Reported complications include filter migration, tilt, and thrombosis, with increased risks during retrieval. Long-term complications may involve vena cava erosion and post-thrombotic syndrome, particularly with extended filter placement.
Evidence Limitations
Current evidence is limited by a lack of large-scale randomized controlled trials. Many studies focus on retrospective data, and there is a need for more prospective research to better understand long-term outcomes and refine retrieval techniques.
Frequently Asked Questions
What are the clinical indications for vena cava filter?
The vena cava filter is indicated for preventing thromboembolism in patients with contraindications to anticoagulation, such as those with deep venous thrombosis or cancer-associated thrombosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective prevention of thromboembolism, particularly in high-risk patients, with noted complications increasing over time.
What complications have been reported?
Safety data from evidence indicate complications such as filter migration, tilt, thrombosis, and vena cava erosion, especially with prolonged use.
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.