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
FDA Clearance Information
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
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
Reported Outcomes
Safety Profile
Evidence Limitations
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)
Two-Year Outcomes from the Cook Inferior Vena Cava Filter (CIVC) Study.
Journal of vascular and interventional radiology : JVIR
Prospective View Source →Management of failed inferior vena cava filter retrieval for complex cases: A case series.
Journal of clinical imaging science
View Source →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 →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 →Complications and retrieval characteristics of Celect Platinum inferior vena cava filters.
Journal of vascular surgery. Venous and lymphatic disorders
Retrospective View Source →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 →Initial experience in 115 patients with the retrievable Cook Celect vena cava filter.
Journal of medical imaging and radiation oncology
Retrospective View Source →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 →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 →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.