📊 Evidence-Based Reference

Denali Vena Cava Filter System Femoral and Jugular Subclavian Delivery Kit

Summary: The Denali Vena Cava Filter System by Bd is a device used for the prevention of pulmonary embolism. Key evidence highlights its retrievability and safety profile in various clinical settings.

FDA Clearance Information

Pathway ? 510(k)

Number ? K240257 ↗

Decision Date ? February 29, 2024

Product Code ? DTK Filter, Intravascular, Cardiovascular

Device Class ? Class 2

Evidence ? 8 studies

The Denali Vena Cava Filter System was cleared by the FDA via the 510k pathway on February 29, 2024. It is manufactured by Bd and classified as a Class 2 medical device.

What It Is

The Denali Vena Cava Filter System is designed for the prevention of pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for temporary or permanent placement, with options for retrieval.

FDA-Cleared Indications

Prevention of pulmonary embolism in patients at risk for venous thromboembolism.
Use when anticoagulant therapy is contraindicated, ineffective, or not tolerated.
Placement in the inferior vena cava through femoral, jugular, or subclavian venous access.

Clinical Applications

Temporary inferior vena cava filtration for patients at risk of pulmonary embolism who cannot receive anticoagulation.
Permanent inferior vena cava filtration when ongoing protection from pulmonary embolism is clinically indicated.
Placement through femoral venous access.
Placement through jugular or subclavian venous access.
Optional retrieval when the risk of pulmonary embolism has decreased and removal is clinically appropriate.

Evidence Summary

The literature includes 10 studies ranging from 2020 to 2025, encompassing RCTs, prospective, and retrospective analyses. These studies evaluate the device's retrievability, safety, and clinical outcomes.

Reported Outcomes

Published studies report effective prevention of pulmonary embolism with the Denali filter, with high retrieval success rates. Propensity score-matching analysis indicates comparable performance to other filters in terms of tilting and retrievability.

Safety Profile

Reported complications include filter tilting, penetration of the IVC wall, and challenges in retrieval due to filter attachment to the vessel wall. However, overall safety profiles are consistent with other IVC filters.

Evidence Limitations

Evidence gaps include limited data on long-term outcomes and complications in smaller IVCs. Further research is needed to optimize retrieval techniques and assess long-term safety.

Practical Considerations

The system is intended for placement in the inferior vena cava using the supplied delivery system; the selected access route depends on anatomy, thrombus location, and procedural planning.
Filter and delivery-system sizing must be matched to the patient's inferior vena cava dimensions and the labeled device specifications.
The device should not be placed when the inferior vena cava anatomy, access route, or thrombus burden is unsuitable according to the product labeling and clinical assessment.
MRI conditions, including field strength and scanning requirements, should be confirmed in the current manufacturer labeling before imaging.
Retrievable filters should be followed after placement, with removal considered when protection is no longer needed and retrieval is clinically feasible.

Procedures that use this device

IVC Filter Placement