📊 Evidence-Based Reference

Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

William Cook Europe ApS

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Summary: The Cook Celect Platinum Vena Cava Filter is a medical device used for preventing pulmonary embolism in patients who cannot undergo anticoagulation therapy. Key evidence highlights its retrievability and management in complex cases.

FDA Clearance Information

Pathway ? 510(k)
Number ? K211875 ↗
Decision Date ? July 28, 2021
Product Code ? DTK Filter, Intravascular, Cardiovascular
Device Class ? Class 2
Evidence ? 11 studies

The Cook Celect Platinum Vena Cava Filter was cleared by the FDA via the 510(k) pathway on July 28, 2021. It is manufactured by William Cook Europe Aps and classified as a Class 2 medical device.

What It Is

The Cook Celect Platinum Vena Cava Filter is designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for use in patients who are contraindicated for anticoagulation therapy.

FDA-Cleared Indications

  • Prevention of pulmonary embolism by trapping thrombi in the inferior vena cava.
  • Use in patients who have thromboembolic disease and are at risk for pulmonary embolism.
  • Use when anticoagulant therapy is contraindicated or ineffective.
  • Placement through a femoral or jugular venous approach.

Clinical Applications

  • Placement in the inferior vena cava for patients at risk of pulmonary embolism who cannot receive anticoagulation.
  • Temporary protection from pulmonary embolism during a period when anticoagulation is contraindicated.
  • Filter placement in selected patients with deep vein thrombosis or other thromboembolic disease.
  • Placement through femoral or internal jugular venous access under imaging guidance.
  • Retrieval when protection from pulmonary embolism is no longer needed and removal is clinically appropriate.

Reported off-label uses

  • Use as an adjunct in selected patients with recurrent pulmonary embolism despite therapeutic anticoagulation.
  • Use in selected patients with large free-floating venous thrombus when clinicians judge the risk of embolization to be high.

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 literature includes 7 studies ranging from 2018 to 2025, covering various study types such as retrospective reviews and case series. These studies focus on retrieval outcomes and management of complex cases.

Reported Outcomes

Published studies report effective retrieval of the Cook Celect Platinum Vena Cava Filter, with successful management of complex retrieval cases. Outcomes indicate the device's utility in preventing pulmonary embolism in high-risk patients.

Safety Profile

Reported complications include filter perforation, migration, and fracture, which vary among filter models. Safety assessments also consider the continuation of anticoagulation therapy during retrieval.

Evidence Limitations

Evidence gaps include limited large-scale randomized controlled trials and long-term follow-up data. Further research is needed to evaluate the mechanical properties of the filter and its long-term safety profile.

Practical Considerations

  • The device is a retrievable IVC filter, but retrieval should be considered when protection is no longer needed because prolonged dwell time can make removal more difficult.
  • It is available in sets for femoral access, jugular access, or either approach; the treating team selects the access route based on venous anatomy, thrombus location, and procedural planning.
  • Placement requires imaging guidance, typically fluoroscopy or other appropriate venography-based imaging, and assessment of IVC diameter and anatomy before deployment.
  • MRI conditions and the device's permitted scan parameters should be confirmed in the current manufacturer instructions for use before MRI.
  • Contraindications and precautions include unsuitable IVC anatomy, access-vessel problems, active infection at the access site, and situations in which the risks of implantation or retrieval outweigh expected benefit.

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

Celect Vena Cava Filter Clinical Trial

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 Platinum Vena Cava Filter?

The device is indicated for preventing pulmonary embolism in patients who cannot undergo anticoagulation therapy.

What outcomes have been reported in clinical studies?

Studies report effective retrieval and management of complex cases, with the device successfully preventing pulmonary embolism.

What complications have been reported?

Safety data indicate complications such as filter perforation, migration, and fracture, with varying incidence among different filter models.

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.

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