đź“Š Evidence-Based Reference
Venatech Convertible Vena Cava Filter System
B Braun Interventional Systems, Inc
Product: Vena Tech — all models and sizes
Summary: The VenaTech Convertible Vena Cava Filter System is designed to prevent pulmonary embolism by filtering blood clots in the inferior vena cava. Key evidence highlights include challenges in filter conversion and hemodynamic effects.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152765 ↗
Decision Date ?
February 26, 2016
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
0 studies
The VenaTech Convertible Vena Cava Filter System was cleared by the FDA via the 510(k) pathway on February 26, 2016. It is manufactured by B. Braun Interventional Systems and classified as a Class II device.
What It Is
The VenaTech Convertible Vena Cava Filter System is a medical device inserted into the inferior vena cava to prevent life-threatening pulmonary embolism. It can be converted into a stent-like structure for long-term use by removing its retrieval hook.
FDA-Cleared Indications
- Filtration of blood clots in the inferior vena cava to help prevent pulmonary embolism.
- Use in patients at risk for pulmonary embolism who have a contraindication to anticoagulation therapy.
- Use when pulmonary embolism occurs despite adequate anticoagulation therapy.
- Use when complications from anticoagulation therapy require an alternative or additional means of pulmonary embolism prevention.
Clinical Applications
- Placement in the inferior vena cava for mechanical pulmonary embolism protection.
- Temporary IVC filtration when anticoagulation is contraindicated or ineffective.
- IVC filtration in selected patients with venous thromboembolism who cannot receive adequate anticoagulation.
- Conversion to a stent-like configuration when continued filtration is no longer desired, according to the device labeling and physician assessment.
Reported off-label uses
- Prophylactic IVC filter placement in selected patients considered at exceptionally high risk for pulmonary embolism without documented venous thromboembolism.
- Use in selected trauma or surgical patients when anticoagulation is temporarily unavailable, although practice varies and is not universally recommended.
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 8 studies ranging from case reports to multicenter trials, published between 2018 and 2025. These studies explore conversion challenges, hemodynamic analysis, and device-related adverse events.
Reported Outcomes
Published studies report variable success in filter conversion, with some cases of incomplete expansion. Hemodynamic studies suggest potential impacts on IVC patency. A multicenter trial indicated successful conversion rates and monitored adverse events over six months.
Safety Profile
Reported complications include chronic IVC occlusion due to incomplete filter expansion and hazardous situations during conversion. Adverse events were documented in follow-up studies, emphasizing the need for careful management.
Evidence Limitations
The evidence is limited by a lack of high-quality, long-term studies on the filter's conversion and its effects. Further research is needed to fully understand the hemodynamic implications and long-term safety of the device.
Practical Considerations
- The device is delivered through a catheter, commonly using femoral or internal jugular venous access, with fluoroscopic imaging to position it in the IVC.
- The appropriate filter size and delivery system depend on IVC diameter and anatomy; vessel measurements should be confirmed before placement.
- Conversion requires a dedicated procedure to remove or alter the filter's retrieval component and should be performed only when clinically appropriate and technically feasible.
- MRI conditions and scan limitations should be verified in the current manufacturer instructions for use before imaging.
- Contraindications and precautions include unsuitable IVC anatomy, venous access limitations, active infection at the access site, and inability to safely perform the procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for VenaTech Convertible Vena Cava Filter System?
The device is indicated for patients at risk of pulmonary embolism, especially those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report successful filter conversion rates and highlight challenges in achieving complete expansion, with follow-up on adverse events.
What complications have been reported?
Safety data indicate complications such as chronic IVC occlusion and hazardous situations during filter conversion.
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.