📊 Evidence-Based Reference

Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit

Summary: The Bard Denali Filter System is a medical device used for the prevention of pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence includes a case study on retrieval challenges and an ongoing clinical trial.

FDA Clearance Information

Pathway ? 510(k)

Number ? K130366 ↗

Decision Date ? May 15, 2013

Product Code ? DTK Filter, Intravascular, Cardiovascular

Device Class ? Class 2

Evidence ? 8 studies

The Bard Denali Filter System was cleared by the FDA through the 510(k) pathway on May 15, 2013. It is manufactured by C.R. Bard and classified as a Class 2 medical device.

What It Is

The Bard Denali Filter System is designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. It is intended for temporary or permanent placement in patients at risk of venous thromboembolism.

FDA-Cleared Indications

Prevention of recurrent pulmonary embolism through placement in the inferior vena cava.
Use in patients who have contraindications to anticoagulation therapy.
Use in patients who have experienced complications from anticoagulation therapy.
Use in patients who have failed adequate anticoagulation therapy.

Clinical Applications

Placement of a retrievable IVC filter in patients at risk for pulmonary embolism.
Temporary protection from pulmonary embolism when anticoagulation cannot be used.
Placement through femoral venous access.
Placement through jugular venous access.
Filter retrieval when protection from pulmonary embolism is no longer clinically needed and retrieval is appropriate.

Evidence Summary

The available literature includes a case study published in 2022 and an ongoing clinical trial. The studies focus on retrieval techniques and the device's role in preventing pulmonary embolism.

Reported Outcomes

Published studies report challenges in filter retrieval due to tilting and attachment to the vessel wall. The ongoing trial aims to assess the device's efficacy in preventing pulmonary embolism.

Safety Profile

Reported complications include difficulty in retrieval due to filter tilt and vessel wall attachment. No other adverse events are detailed in the provided evidence.

Evidence Limitations

The evidence is limited to a single case study and an ongoing trial, highlighting the need for more comprehensive research on long-term outcomes and safety. Further studies are required to establish broader efficacy and safety profiles.

Practical Considerations

The system includes femoral and jugular delivery kits; the access route is selected based on venous anatomy, thrombus location, and the planned filter position.
Deployment is performed under fluoroscopic or other appropriate imaging guidance, typically with local anesthetic and sometimes moderate sedation.
The filter is intended for placement in the infrarenal IVC unless the treating physician determines that another position is clinically appropriate.
MRI conditions and scan parameters should be confirmed in the current manufacturer labeling before imaging; patients should tell MRI staff that an IVC filter is present.
Potential concerns include filter migration, fracture, tilt, perforation, IVC thrombosis, and difficulty with retrieval. Retrieval timing should be assessed by the treating clinician because prolonged dwell time can make removal more difficult.

Procedures that use this device

IVC Filter Placement