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bard denali filter system- femoral delivery kit and jugular delivery kit
C.R. Bard
Summary: The Bard Denali Filter System is a medical device used for the prevention of pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence includes a case study on retrieval challenges and an ongoing clinical trial.
FDA Clearance Information
Pathway 510K
Number K130366 ↗
Decision Date May 15, 2013
Product Code DTK
Device Class Class 2
Evidence 8 studies
The Bard Denali Filter System was cleared by the FDA through the 510(k) pathway on May 15, 2013. It is manufactured by C.R. Bard and classified as a Class 2 medical device.
What It Is
The Bard Denali Filter System is 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
This device is commonly used in patients with a high risk of pulmonary embolism, especially those who cannot undergo anticoagulation therapy. It is deployed via femoral or jugular access.
Evidence Summary
The available literature includes a case study published in 2022 and an ongoing clinical trial. The studies focus on retrieval techniques and the device's role in preventing pulmonary embolism.
Reported Outcomes
Published studies report challenges in filter retrieval due to tilting and attachment to the vessel wall. The ongoing trial aims to assess the device's efficacy in preventing pulmonary embolism.
Safety Profile
Reported complications include difficulty in retrieval due to filter tilt and vessel wall attachment. No other adverse events are detailed in the provided evidence.
Evidence Limitations
The evidence is limited to a single case study and an ongoing trial, highlighting the need for more comprehensive research on long-term outcomes and safety. Further studies are required to establish broader efficacy and safety profiles.
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 Bard Denali Filter System?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot receive anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report challenges in retrieval due to filter tilt and attachment, with ongoing research assessing efficacy in preventing pulmonary embolism.
What complications have been reported?
Safety data indicate complications related to retrieval difficulties, such as filter tilt and vessel wall 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.