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Gunther Tulip Vena Cava Filter Set
Summary: The Gunther Tulip Vena Cava Filter Set is a medical device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence highlights its efficacy and safety in various clinical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K043509 ↗
Decision Date ?
May 5, 2005
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
10 studies
The Gunther Tulip Vena Cava Filter Set was cleared by the FDA via the 510(k) pathway on May 5, 2005. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Gunther Tulip Vena Cava Filter is a retrievable filter designed to prevent pulmonary embolism by capturing thrombi 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 by placement in the inferior vena cava.
- Use in patients who have venous thromboembolism and a contraindication to anticoagulation.
- Use when pulmonary embolism occurs despite adequate anticoagulation, when placement of an IVC filter is clinically indicated.
Clinical Applications
- Placement in the inferior vena cava to capture embolizing venous thrombi.
- Temporary or retrievable filtration when anticoagulation cannot be used or is not appropriate.
- IVC filter placement for patients with venous thromboembolism who remain at risk for pulmonary embolism despite anticoagulation.
Reported off-label uses
- Prophylactic placement in selected trauma patients who do not have confirmed venous thromboembolism but are considered to have a very high risk of pulmonary embolism.
- Temporary prophylactic placement before selected major surgical procedures in patients considered to have unusually high thromboembolic risk.
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 11 studies, comprising case series and retrospective analyses, published between 2011 and 2020. These studies evaluate the filter's efficacy, safety, and retrieval outcomes.
Reported Outcomes
Published studies report that the Gunther Tulip Vena Cava Filter effectively prevents pulmonary embolism in patients with contraindications to anticoagulation. Midterm outcomes indicate satisfactory filter integrity and efficacy. Successful retrievals have been documented, even in complex cases involving filter migration or embedding.
Safety Profile
Reported complications include filter migration, embedding into the vena cava wall, and difficulty in retrieval. Some cases involved filter perforation of the vena cava wall, particularly after long-term implantation.
Evidence Limitations
The evidence is primarily based on retrospective studies and case series, which may limit the generalizability of findings. Further prospective studies are needed to better understand long-term safety and efficacy outcomes.
Practical Considerations
- The filter is delivered through a catheter, commonly from a femoral or jugular venous access site, under fluoroscopic imaging.
- Available filter and delivery-system sizes, access requirements, and retrieval features must be confirmed in the current Cook instructions for use and matched to the patient's IVC anatomy.
- The device is intended for retrievable use, but retrieval depends on the patient's clinical status, filter position, clot burden, endothelialization, and local practice; it may remain permanently when removal is not appropriate.
- MRI conditions and the permitted field strength or scanning parameters should be verified in the current device labeling before MRI.
- Potential complications include access-site bleeding, filter migration or tilt, caval thrombosis or perforation, fracture, recurrent deep-vein thrombosis, and difficulty removing the filter. Anticoagulation remains the standard treatment for venous thromboembolism when it can be safely given.
Procedures that use this device
Linked Studies (10)
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 • 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 • 2014
Safety and efficacy of the Gunther Tulip retrievable vena cava filter: midterm outcomes.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Successful removal of a Gunther tulip vena cava filter with wall-embedded hook and migration during a retrieval attempt.
Acta radiologica short reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Retrieval of gunther tulip vena cava filter with thrombosed hook and a leg incorporated into the vena cava wall.
Annals of vascular diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
Endovascular repair of a perforation of the vena caval wall caused by the retrieval of a Gunther Tulip filter after long-term implantation.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2008
Form and function of vena cava filters: how do optional filters measure up?
Vascular
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2007
Evaluation of retrievability of the Gunther tulip vena cava filter.
Cardiovascular and interventional radiology
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 Gunther Tulip Vena Cava Filter?
The filter is indicated for preventing pulmonary embolism in patients with contraindications to anticoagulation or those with recurrent thromboembolic events.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, satisfactory midterm filter integrity, and successful retrievals, even in complex cases.
What complications have been reported?
Safety data indicate complications such as filter migration, embedding, and vena cava wall perforation, particularly with long-term implantation.
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.