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Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
Summary: The Gunther Tulip Vena Cava Filter 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 ?
K172557 ↗
Decision Date ?
November 20, 2017
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
10 studies
The Gunther Tulip Vena Cava Filter was cleared by the FDA via the 510(k) pathway on November 20, 2017. It is manufactured by William Cook Europe Aps and is classified as a Class II medical device.
What It Is
The Gunther Tulip Vena Cava Filter is a retrievable filter designed for placement in the inferior vena cava to prevent pulmonary embolism. It can be deployed via femoral or jugular vein approaches and is intended for temporary or permanent use.
FDA-Cleared Indications
- Prevention of pulmonary embolism by placement of a filter in the inferior vena cava.
- Use in patients who have venous thromboembolism and a contraindication to anticoagulation.
- Use when pulmonary embolism occurs despite appropriate anticoagulation.
- Temporary or permanent IVC filtration when clinically indicated.
Clinical Applications
- Placement in the inferior vena cava to help prevent pulmonary embolism.
- Use in patients with deep vein thrombosis who cannot receive anticoagulant medication.
- Use in patients with recurrent pulmonary embolism despite anticoagulation.
- Retrievable filter placement when protection from pulmonary embolism is expected to be temporary.
- Femoral-vein or jugular-vein access for IVC filter deployment.
Reported off-label uses
- Prophylactic placement in selected trauma patients who do not have confirmed venous thromboembolism.
- Prophylactic placement in selected patients undergoing major surgery who have a high risk of venous thromboembolism.
- Filter placement to protect against embolization during selected venous interventions.
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 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 high-risk patients. Midterm outcomes indicate satisfactory filter integrity and efficacy, with successful retrieval in many cases.
Safety Profile
Reported complications include filter migration, perforation of the vena cava wall, and difficulty in retrieval due to thrombus entanglement or filter tilt. These events highlight the importance of careful patient selection and monitoring.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and small sample sizes. Further prospective research is needed to better understand long-term outcomes and optimize retrieval techniques.
Practical Considerations
- The filter is delivered through a catheter introduced from the femoral or internal jugular vein; imaging is used to confirm IVC anatomy and filter position.
- Available filter and delivery-system sizes, access-site requirements, and retrieval compatibility must be checked in the current manufacturer instructions for use.
- The device should not be placed when the IVC anatomy, thrombus burden, or access route is unsuitable, or when the patient has a contraindication identified in the labeling.
- Retrievable filters should be evaluated for removal when protection is no longer needed; prolonged dwell time can increase risks such as filter tilt, fracture, migration, or caval thrombosis.
- MRI conditions and scan limits should be confirmed in the current manufacturer labeling before imaging.
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 patients at risk of pulmonary embolism, especially those with contraindications to anticoagulation or recurrent embolism despite therapy.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism and satisfactory midterm filter integrity and efficacy.
What complications have been reported?
Complications include filter migration, vena cava wall perforation, and retrieval difficulties due to thrombus or filter tilt.
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.