Gunther Tulip Vena Cava Filter Cook Celect Vena Cava Filter
Product: Cook Celect — all models and sizes
FDA Clearance Information
The Gunther Tulip Vena Cava Filter was cleared by the FDA through the 510(k) pathway on April 3, 2009. 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 with thromboembolic disease when anticoagulation is contraindicated.
- Use when thromboembolic disease persists or recurs despite anticoagulant therapy.
Clinical Applications
- Placement in the inferior vena cava for pulmonary embolism protection.
- Temporary placement when protection is needed during a period in which anticoagulation cannot be used.
- Retrieval after the risk of pulmonary embolism has decreased, when clinically appropriate.
- Permanent placement when an IVC filter is still indicated and retrieval is not planned.
Reported off-label uses
- Prophylactic placement in selected trauma patients without documented venous thromboembolism.
- Prophylactic placement before certain high-risk surgeries or procedures in patients considered at elevated risk for pulmonary embolism.
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 filter is delivered through a catheter, commonly using venous access in the neck or groin, with fluoroscopic imaging to position it in the IVC.
- Filter sizing and placement depend on IVC diameter, anatomy, thrombus location, and the specific device instructions for use.
- Patients should be evaluated for retrieval when the risk of pulmonary embolism has decreased; prolonged dwell time can make retrieval more difficult and may increase device-related complications.
- MRI conditions, including field strength and other limits, must be confirmed in the current manufacturer labeling before scanning.
- An IVC filter does not treat existing deep vein thrombosis or replace anticoagulation when anticoagulation is safe and indicated.
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 Gunther Tulip Vena Cava Filter?
The filter is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy or have recurrent embolism despite treatment.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, with satisfactory midterm filter integrity and successful retrieval in challenging scenarios.
What complications have been reported?
Safety data indicate complications such as filter migration, vena cava wall perforation, and retrieval difficulties due to thrombus or embedding.