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gunther tulip vena cava filter set for femoral vein approach gunther tulip vena cava filter set for femoral and jugular vein approach
William Cook Europe Aps
Summary: The Gunther Tulip Vena Cava Filter is a device used to prevent pulmonary embolism by capturing blood clots. Key evidence highlights its retrieval challenges and complications.
FDA Clearance Information
Pathway 510K
Number K172584 ↗
Decision Date November 20, 2017
Product Code DTK
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 2 medical device.
What It Is
The Gunther Tulip Vena Cava Filter is a medical device designed to capture blood clots in the inferior vena cava to prevent pulmonary embolism. It is intended for temporary or permanent placement in patients at risk of thromboembolic events.
Clinical Applications
Commonly used in patients with contraindications to anticoagulation therapy or those who have experienced recurrent thromboembolic events despite anticoagulation. It is placed via femoral or jugular vein approaches.
Evidence Summary
The available literature includes 11 studies, comprising case reports and retrospective analyses, published between 2011 and 2020. These studies explore the device's efficacy, retrieval challenges, and safety profile.
Reported Outcomes
Published studies report that the Gunther Tulip Vena Cava Filter is effective in preventing pulmonary embolism. However, retrieval can be challenging, especially if the filter becomes embedded in the vena cava wall or migrates. Successful retrievals have been documented using alternative techniques.
Safety Profile
Reported complications include filter migration, embedding in the vena cava wall, and perforation of the vena cava. These events can complicate retrieval and may require endovascular repair.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of most reports. Further research is needed to assess long-term outcomes and optimize retrieval techniques.
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 who cannot undergo anticoagulation therapy or have recurrent thromboembolic events.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, but retrieval challenges and complications such as migration and embedding are noted.
What complications have been reported?
Safety data indicate complications such as filter migration, embedding in the vena cava wall, and vena cava perforation.
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.