📊 Evidence-Based Reference

Denali Filter System - Femoral Delivery Kit Denali Filter System - Jugular Subclavain Delivery Kit

Summary: The Denali Filter System by C.R. Bard is an FDA-cleared device used for preventing pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence includes studies on retrieval challenges and radiographic findings.

FDA Clearance Information

Pathway ? 510(k)

Number ? K143208 ↗

Decision Date ? December 9, 2014

Product Code ? DTK Filter, Intravascular, Cardiovascular

Device Class ? Class 2

Evidence ? 8 studies

The Denali Filter System was cleared by the FDA through the 510(k) pathway on December 9, 2014. It is manufactured by C.R. Bard and classified as a Class 2 medical device.

What It Is

The Denali Filter System is a medical device 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 pulmonary embolism by trapping thrombi in the inferior vena cava.
Use in patients at risk for venous thromboembolism when protection from pulmonary embolism is clinically indicated.
Placement through femoral, jugular, or subclavian venous access using the corresponding delivery kit.

Clinical Applications

Percutaneous placement of an IVC filter in the inferior vena cava.
Pulmonary embolism protection for patients with venous thromboembolism who cannot receive anticoagulation.
Temporary or permanent IVC filter placement when clinically indicated for thromboembolic disease.
Use with imaging guidance to position and deploy the filter in the IVC.

Reported off-label uses

Prophylactic placement in selected patients considered to have a very high risk of pulmonary embolism but no documented venous thromboembolism.
Placement in selected trauma or surgical patients when anticoagulation is temporarily contraindicated.

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 three studies: a case report from 2022, a retrospective study from 2017, and an ongoing clinical trial. These studies explore retrieval techniques, radiographic findings, and preventive efficacy.

Reported Outcomes

Published studies report challenges in filter retrieval due to tilt and attachment to vessel walls. Radiographic studies highlight the association between device distress and venous stenosis or occlusion. Ongoing trials aim to assess preventive efficacy against pulmonary embolism.

Safety Profile

Reported complications include difficulty in retrieval due to filter tilt and vessel wall attachment. Radiographic findings suggest potential venous stenosis or occlusion associated with device placement.

Evidence Limitations

The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to evaluate long-term safety and efficacy, as well as optimal retrieval techniques.

Practical Considerations

The system includes femoral and jugular/subclavian delivery kits; the access route is selected based on venous anatomy, thrombus location, and the planned filter position.
Placement is generally performed with fluoroscopic imaging, often with local anesthesia and moderate sedation.
The filter may be intended for temporary retrieval or left in place permanently; retrieval planning and follow-up are important because long-term indwelling filters can develop complications.
Before placement, clinicians assess for IVC thrombosis, abnormal IVC anatomy, infection, bleeding risk, and other contraindications to venous access or filter deployment.
MRI conditions and device-specific size, deployment, and retrieval instructions should be confirmed in the current manufacturer labeling before MRI or intervention.

Procedures that use this device

IVC Filter Placement