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vena cava filter systems modification
B. Braun Vena-Tech
Summary: The Vena-Tech vena cava filter system by B. Braun is designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. Key evidence highlights trends in filter usage and safety post-FDA warnings.
FDA Clearance Information
Pathway
510K
Number
K925679 ↗
Decision Date
November 27, 1992
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Vena-Tech vena cava filter system was cleared by the FDA through the 510(k) pathway on November 27, 1992. It is manufactured by B. Braun and classified as a Class 2 medical device.
What It Is
The Vena-Tech vena cava filter is a medical device implanted in the inferior vena cava to capture blood clots and prevent pulmonary embolism. It is intended for patients at risk of thromboembolic events.
Clinical Applications
This device is commonly used in patients who are at high risk of pulmonary embolism, particularly when anticoagulation therapy is contraindicated or ineffective. It is often used in trauma, surgical, or critically ill patients.
Evidence Summary
The literature includes 9 studies, ranging from 2003 to 2024, encompassing various study types such as RCTs and retrospective analyses. These studies evaluate trends in filter usage, safety, and efficacy.
Reported Outcomes
Published studies report a decrease in overall inferior vena cava filter utilization following FDA safety warnings. The effectiveness of the filter in capturing thrombi and preventing pulmonary embolism has been evaluated in both human and animal models.
Safety Profile
Reported complications include device migration, filter fracture, and thrombosis at the filter site. The FDA has issued safety warnings to monitor and report adverse events associated with these filters.
Evidence Limitations
Evidence gaps include a lack of long-term outcome data and limited high-quality randomized controlled trials. Further research is needed to assess the long-term safety and efficacy of these devices.
Frequently Asked Questions
What are the clinical indications for vena cava filter systems?
The device is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation is contraindicated or ineffective.
What outcomes have been reported in clinical studies?
Studies report decreased filter usage post-FDA warnings and effectiveness in thrombus capture.
What complications have been reported?
Complications include device migration, filter fracture, and thrombosis at the filter site.
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.