📊 Evidence-Based Reference

denali filter system - femoral delivery kit denali filter system - jugular subclavian delivery kit

C.R. Bard

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 510K

Number K160866 ↗

Decision Date April 29, 2016

Product Code DTK

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.

Clinical Applications

Commonly used in patients at risk of pulmonary embolism, particularly those with contraindications to anticoagulation therapy. It is deployed via femoral, jugular, or subclavian access.

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.

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 →

ClinicalTrials.gov

ODEN Trial: Option vs. Denali IVC Filters

View Source →

Frequently Asked Questions

What are the clinical indications for Denali Filter System?

The Denali Filter System is indicated for the prevention of pulmonary embolism in patients with contraindications to anticoagulation.

What outcomes have been reported in clinical studies?

Studies have reported challenges in retrieval due to filter tilt and vessel wall attachment, and associations with venous stenosis.

What complications have been reported?

Safety data indicate complications such as difficulty in retrieval due to filter tilt and attachment to the vessel wall.

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.