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vena tech vena cava filter vena tech 30d vena cava filter vena tech lp cave filter
Bbraun
Summary: The Vena Tech Vena Cava Filter by Bbraun is a device used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. Key evidence highlights its efficacy in maintaining caval patency and preventing embolism.
FDA Clearance Information
Pathway
510K
Number
K010485 ↗
Decision Date
May 18, 2001
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Vena Tech Vena Cava Filter was cleared by the FDA via the 510(k) pathway on May 18, 2001. It is manufactured by Bbraun and classified as a Class II medical device.
What It Is
The Vena Tech Vena Cava Filter is a medical device designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for percutaneous placement and is used in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients with a high risk of pulmonary embolism, the Vena Tech Vena Cava Filter is placed in the inferior vena cava to intercept blood clots. It is particularly useful in patients who cannot be managed with anticoagulation therapy alone.
Evidence Summary
The literature includes five studies, encompassing case series and other study types, with publication dates ranging from 1991 to 2002. These studies provide insights into the device's efficacy and safety profile.
Reported Outcomes
Published studies report that the Vena Tech Vena Cava Filter is effective in preventing pulmonary embolism, with two cases of embolism noted in one study. The filter also maintains caval patency, with three cases of thrombosis and two instances of recanalization reported.
Safety Profile
Reported complications include filter tilt and migration, though these were not clinically significant. One study noted a broken filter, highlighting the importance of monitoring for mechanical stability.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and compare the device with other filters.
Frequently Asked Questions
What are the clinical indications for Vena Tech Vena Cava Filter?
The Vena Tech Vena Cava Filter 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 have reported the filter's efficacy in preventing pulmonary embolism and maintaining caval patency, with some instances of thrombosis and recanalization.
What complications have been reported?
Safety data indicate complications such as filter tilt, migration, and one instance of a broken filter, though these were generally not clinically significant.
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.