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vena cava filter
Vena-Tech
Summary: The Vena-Tech vena cava filter is a medical device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence highlights complications associated with retrieval and long-term use.
FDA Clearance Information
Pathway
510K
Number
K881604 ↗
Decision Date
March 10, 1989
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Vena-Tech vena cava filter was cleared by the FDA via the 510k pathway on March 10, 1989. It is manufactured by Vena-Tech and classified as a Class 2 medical device.
What It Is
The vena cava filter is a device designed to prevent pulmonary embolism by trapping blood clots traveling from the lower extremities to the lungs. It is typically used in patients who cannot undergo anticoagulation therapy.
Clinical Applications
Commonly used in patients with deep vein thrombosis who have contraindications to anticoagulation, or in high-risk scenarios such as trauma or critical illness where thromboembolic events are a concern.
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 use.
Reported Outcomes
Published studies report that vena cava filters are effective in preventing pulmonary embolism in high-risk patients. However, there is a noted increase in complications during retrieval, especially with prolonged dwell times.
Safety Profile
Reported complications include filter migration, tilt, and thrombosis, as well as long-term issues such as caval erosion and post-thrombotic syndrome. Retrieval complications increase with longer implantation periods.
Evidence Limitations
Current evidence is limited by a lack of large-scale randomized controlled trials. Many studies are retrospective or case series, highlighting the need for more robust prospective research to better understand long-term outcomes and safety.
Frequently Asked Questions
What are the clinical indications for vena cava filter?
Indications include prevention of pulmonary embolism in patients with contraindications to anticoagulation, and prophylactic use in high-risk trauma or critically ill patients.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, but highlight increased complications with longer filter dwell times.
What complications have been reported?
Safety data indicate complications such as filter migration, tilt, thrombosis, and long-term caval erosion, with increased retrieval difficulties over time.
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.