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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 ?
510(k)
Number ?
K010485 ↗
Decision Date ?
May 18, 2001
Product Code ?
DTK Filter, Intravascular, Cardiovascular
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.
FDA-Cleared Indications
- Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
- Use in patients at risk for thromboembolic disease when protection from pulmonary embolism is indicated.
- Percutaneous placement in the inferior vena cava.
Clinical Applications
- Percutaneous inferior vena cava filter placement for pulmonary embolism prevention.
- Protection from pulmonary embolism in patients with venous thromboembolism who cannot receive anticoagulation.
- Pulmonary embolism prevention when anticoagulation is ineffective or inadequate.
- Placement in the inferior vena cava to intercept thrombi traveling from the lower extremities or pelvis.
Reported off-label uses
- Prophylactic placement in selected patients without documented venous thromboembolism but considered to have a high risk of pulmonary embolism.
- Use in selected patients with free-floating or large proximal deep-vein thrombi when clinicians judge pulmonary embolism risk to be substantial.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The filter is intended for placement in the inferior vena cava; imaging is used to evaluate caval anatomy, thrombus, and renal-vein location before deployment.
- Available model and filter sizes must be matched to the patient's inferior vena cava diameter and the compatible delivery system described in the applicable instructions for use.
- Contraindications and precautions include unsuitable caval anatomy, significant thrombus at the intended deployment site, infection at the access site, and inability to safely obtain venous access.
- The access route, sedation or anesthesia, retrieval capability, and whether the specific model is permanent or retrievable must be confirmed before the procedure; device-specific labeling governs MRI conditions.
- Potential complications include access-site bleeding, filter migration or tilt, caval perforation, filter thrombosis, recurrent deep-vein thrombosis, and pulmonary embolism despite placement.
Procedures that use this device
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.