📊 Evidence-Based Reference

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

Summary: The Denali Filter System by C.R. Bard is an IVC filter used to prevent pulmonary embolism. Key evidence includes studies on retrieval challenges and radiographic findings.

FDA Clearance Information

Pathway ? 510(k)

Number ? K160866 ↗

Decision Date ? April 29, 2016

Product Code ? DTK Filter, Intravascular, Cardiovascular

Device Class ? Class 2

Evidence ? 8 studies

The Denali Filter System was cleared by the FDA via the 510(k) pathway on April 29, 2016. It is manufactured by C.R. Bard and classified as a Class 2 medical device.

What It Is

The Denali Filter System is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing blood clots. It is intended for temporary or permanent placement in the IVC.

FDA-Cleared Indications

Prevention of pulmonary embolism by capturing thrombi in the inferior vena cava.
Use in patients who have thromboembolic disease and are at risk for pulmonary embolism.
Use when anticoagulation therapy is contraindicated, unsuccessful, or not sufficient to prevent pulmonary embolism.

Clinical Applications

Placement of an IVC filter through femoral venous access.
Placement of an IVC filter through jugular or subclavian venous access.
Temporary or permanent placement in the inferior vena cava for pulmonary embolism protection.
Use in patients who cannot receive anticoagulation or who remain at risk for pulmonary embolism despite anticoagulation.

Reported off-label uses

Prophylactic placement in selected patients without documented venous thromboembolism but considered to have a high risk of pulmonary embolism.
Use for selected patients with recurrent pulmonary embolism despite anticoagulation.

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 available literature includes three studies, with types ranging from case series to prospective studies. The studies were published between 2017 and 2022.

Reported Outcomes

Published studies report challenges in filter retrieval due to tilt and attachment to the vessel wall. Radiographic findings have been associated with venous stenosis or occlusion.

Safety Profile

Reported complications include difficulty in retrieval due to filter tilt and vessel wall attachment. No specific adverse events were detailed in the provided studies.

Evidence Limitations

The evidence is limited by small sample sizes and lack of long-term outcome data. Further research is needed to assess long-term safety and efficacy.

Practical Considerations

The system is available with femoral delivery and jugular/subclavian delivery kits; the access route depends on venous anatomy, thrombus location, and the treatment plan.
Placement is performed under fluoroscopic or other suitable imaging guidance, with venography commonly used to evaluate the IVC before deployment.
The filter should not be placed in an unsuitable IVC, such as one with anatomy, diameter, thrombus, or obstruction that prevents safe deployment; the manufacturer’s labeling and sizing requirements must be followed.
If retrieval is planned, the patient should receive follow-up evaluation because delayed retrieval can become more difficult and may increase the risk of filter-related complications.
MRI eligibility, including scanner strength and conditions for use, should be confirmed in the current manufacturer’s labeling before scanning; the presence of an IVC filter does not by itself replace an MRI safety review.

Procedures that use this device

IVC Filter Placement