đź“Š Evidence-Based Reference
denali filter system - femoral delivery kit denali filter system - jugular subclavain delivery kit
C.R. Bard
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 510K
Number K143208 ↗
Decision Date December 9, 2014
Product Code DTK
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.
Clinical Applications
Commonly used in patients with a history of deep vein thrombosis or pulmonary embolism, the Denali Filter System is deployed in the inferior vena cava to prevent further embolic events, especially when anticoagulation therapy is contraindicated.
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.
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 Filter System?
The Denali Filter System is indicated for patients at risk of pulmonary embolism, particularly when anticoagulation therapy is contraindicated.
What outcomes have been reported in clinical studies?
Studies report challenges in retrieval due to filter tilt and vessel wall attachment, and radiographic findings of venous stenosis or occlusion.
What complications have been reported?
Reported complications include difficulty in retrieval and potential venous stenosis or occlusion associated with the device.
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.