📋 FDA Reference
Venatech R LP Vena Cava Filter System and Venatech R Convertible Vena Cava Filter System
Summary: The Venatech R LP Vena Cava Filter System is a medical device used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K240578 ↗
Decision Date ?
July 31, 2024
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
0 studies
The Venatech R LP Vena Cava Filter System, manufactured by B. Braun Medical, received FDA clearance through the 510k pathway on July 31, 2024. It is classified as a Class 2 device under product code DTK.
What It Is
The Venatech R LP Vena Cava Filter System is designed to capture emboli (blood clots) in the inferior vena cava (IVC), preventing them from reaching the lungs and causing a pulmonary embolism. The filter is typically inserted via a minimally invasive procedure, often through a femoral or jugular vein approach. The convertible version allows for potential retrieval or conversion to a permanent filter, offering flexibility in patient management.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for pulmonary embolism.
- Use in patients who have contraindications to anticoagulation therapy.
- Placement in the inferior vena cava to capture emboli traveling from the lower extremities or pelvic veins.
Clinical Applications
- Percutaneous IVC filter placement for patients at risk of pulmonary embolism who cannot receive anticoagulants.
- Temporary protection from pulmonary embolism when the contraindication to anticoagulation may resolve.
- Use of the convertible filter system when the treating physician determines that conversion or retrieval may be appropriate based on the patient's clinical condition.
Reported off-label uses
- Selected patients with recurrent pulmonary embolism despite therapeutic anticoagulation.
- Selected patients with a large free-floating iliofemoral or IVC thrombus when pulmonary embolism risk is considered unusually high.
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.
Practical Considerations
- The filter is placed through a venous access site, commonly the femoral or internal jugular vein, using fluoroscopic imaging.
- The selected filter size and delivery system must match the patient's IVC diameter, anatomy and access route.
- The decision to place, retrieve or convert a filter should balance pulmonary embolism risk against complications such as filter migration, fracture, thrombosis, perforation or difficult retrieval.
- MRI compatibility and conditions should be confirmed in the current manufacturer instructions for use before scanning.
- An IVC filter does not treat the underlying deep vein thrombosis, and anticoagulation may be started or resumed when clinically appropriate.
Procedures that use this device
Frequently Asked Questions
What is the Venatech R LP Vena Cava Filter used for?
It is used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for patients at risk of pulmonary embolism who cannot be treated with anticoagulants.
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.