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denali vena cava filter system femoral and jugular subclavian delivery kit
Bd
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 510K
Number K240257 ↗
Decision Date February 29, 2024
Product Code DTK
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.
Clinical Applications
Commonly used in patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy. It is deployed via femoral or jugular/subclavian access, providing a mechanical barrier to thromboemboli.
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.
Linked Studies (8)
PubMed • 2024
Characteristics of Option and Denali Inferior Vena Cava Filters.
Annals of vascular surgery
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Filter tilting and retrievability of the Celect and Denali inferior vena cava filters using propensity score-matching analysis.
European journal of radiology open
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2022
Device for retrieval of vena cava filter with combination of a multi-loop snare and Amplatz catheter.
SAGE open medical case reports
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2018
Denali, Tulip, and Option Inferior Vena Cava Filter Retrieval: A Single Center Experience.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2018
Retrieval characteristics of the Bard Denali and Argon Option inferior vena cava filters.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2017
Bard Denali Filter Fractures.
Journal of vascular and interventional radiology : JVIR
View Source → ClinicalTrials.gov
A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System
View Source →Frequently Asked Questions
What are the clinical indications for Denali Vena Cava Filter System?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism and high retrieval success rates, with performance comparable to other filters.
What complications have been reported?
Safety data indicate complications such as filter tilting, IVC wall penetration, and retrieval challenges due to filter attachment.
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.