đź“Š Evidence-Based Reference
venatech convertible vena cava filter system
B. Braun Interventional Systems
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
510K
Number
K152765 ↗
Decision Date
February 26, 2016
Product Code
DTK
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.
Clinical Applications
This device is commonly used in patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy. It is also used in scenarios requiring temporary or permanent IVC filtration.
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.
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.