đź“Š Evidence-Based Reference
Cook Celect Vena Cava Filter
Summary: The Cook Celect Vena Cava Filter is a retrievable filter used to prevent pulmonary embolism. Key evidence highlights successful insertion and retrieval rates, with some complications related to hook endothelialisation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K061815 ↗
Decision Date ?
April 20, 2007
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
11 studies
The Cook Celect Vena Cava Filter was cleared by the FDA via the 510(k) pathway on April 20, 2007. It is manufactured by William Cook Europe Aps and classified as a Class 2 medical device.
What It Is
The Cook Celect Vena Cava Filter is a retrievable device designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for temporary or permanent placement in patients at risk of thromboembolic events.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for thromboembolic disease.
- Use when anticoagulant therapy is contraindicated.
- Use when anticoagulant therapy has failed or is ineffective.
Clinical Applications
- Placement in the inferior vena cava to reduce the risk of pulmonary embolism.
- Temporary placement when protection from pulmonary embolism is needed for a limited period.
- Retrieval after the risk of pulmonary embolism has decreased, when retrieval is clinically appropriate.
- Use in patients who cannot receive anticoagulation because of bleeding risk or another contraindication.
Reported off-label uses
- Placement in selected patients with recurrent pulmonary embolism despite therapeutic anticoagulation.
- Use in selected trauma or surgical patients with a high risk of venous thromboembolism when standard prophylaxis cannot be used.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes a mix of retrospective studies and clinical trials, with a total of 6 studies reviewed. The studies span from 2009 to the present, focusing on the device's performance, retrievability, and safety.
Reported Outcomes
Published studies report a 100% success rate in filter insertion and a 49.6% overall retrieval rate, with a 93.4% success rate from attempted retrievals. These findings suggest the device is effective in its primary function, with high retrieval success when attempted.
Safety Profile
Reported complications include a low overall complication rate, but there are concerns regarding hook endothelialisation, which may impact retrieval. No major adverse events were reported in the studies reviewed.
Evidence Limitations
The evidence is limited by the retrospective nature of some studies and the lack of long-term follow-up data. Further research is needed to assess the long-term safety and efficacy of the device, particularly regarding complications related to endothelialisation.
Practical Considerations
- The filter is deployed in the inferior vena cava, generally below the renal veins, using fluoroscopic or other image guidance.
- Available filter and delivery-system sizes depend on the specific configuration and the patient's IVC diameter; the manufacturer's current instructions for use should be checked before placement.
- Retrieval may become more difficult over time because the filter can tilt, become embedded, or develop hook endothelialisation. A follow-up plan should be established when the device is placed.
- MRI conditions, including field strength and other scanner requirements, must be confirmed in the current manufacturer labeling before imaging.
- The device is not a substitute for anticoagulation when anticoagulation is safe and clinically indicated. Potential complications include access-site bleeding, filter migration, thrombosis, perforation, tilt, and retrieval failure.
Procedures that use this device
Linked Studies (11)
PubMed • 2025
Two-Year Outcomes from the Cook Inferior Vena Cava Filter (CIVC) Study.
Journal of vascular and interventional radiology : JVIR
Prospective View Source →PubMed • 2023
Management of failed inferior vena cava filter retrieval for complex cases: A case series.
Journal of clinical imaging science
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
Case report: Endoluminal removal of a retrievable conical inferior vena cava filter with a ruptured retraction hook attached to the wall.
Frontiers in surgery
Case Report View Source →PubMed • 2018
Complications and retrieval characteristics of Celect Platinum inferior vena cava filters.
Journal of vascular surgery. Venous and lymphatic disorders
Retrospective View Source →PubMed • 2016
Factors affecting Cook Gunther Tulip and Cook Celect inferior vena cava filter retrieval success.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2009
Initial experience in 115 patients with the retrievable Cook Celect vena cava filter.
Journal of medical imaging and radiation oncology
Retrospective View Source →PubMed • 2009
Deployment performance and retrievability of the Cook Celect vena cava filter.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2005
New optional IVC filter for percutaneous retrieval--in vitro evaluation of embolus capturing efficiency.
RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
View Source →Frequently Asked Questions
What are the clinical indications for Cook Celect Vena Cava Filter?
The device is indicated for patients at risk of pulmonary embolism, especially when anticoagulation is contraindicated or ineffective.
What outcomes have been reported in clinical studies?
Studies report a 100% success rate in insertion and a 93.4% success rate in retrieval attempts, with an overall retrieval rate of 49.6%.
What complications have been reported?
Safety data indicate a low complication rate, with some issues related to hook endothelialisation affecting retrieval.
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.