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gunther tulip vena cava mreye filter set
Cook
Summary: The Gunther Tulip Vena Cava MReye Filter Set is a medical device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K000855 ↗
Decision Date October 18, 2000
Product Code DTK
Device Class Class 2
Evidence 10 studies
The Gunther Tulip Vena Cava MReye Filter Set was cleared by the FDA via the 510(k) pathway on October 18, 2000. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Gunther Tulip Vena Cava MReye Filter Set is a type of inferior vena cava (IVC) filter designed to prevent pulmonary embolism by trapping emboli (blood clots) that originate in the lower extremities. It is inserted via a catheter into the IVC and can be retrieved when no longer needed. The device features a unique design that facilitates both implantation and retrieval.
Clinical Applications
This device is commonly used in patients at risk of pulmonary embolism, particularly those who cannot be managed with anticoagulation therapy. It is often employed in trauma centers, surgical settings, and interventional radiology suites. The patient population includes those with deep vein thrombosis, recent surgery, or trauma that predisposes them to clot formation.
Indications for Use
The FDA-cleared indications for this device include prevention of recurrent pulmonary embolism in patients who are at high risk and for whom anticoagulant therapy is contraindicated or has failed. It is suitable for patients with venous thromboembolism.
Practical Considerations
The Gunther Tulip filter is available in various sizes to accommodate different patient anatomies. It is compatible with standard catheterization techniques and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in both the insertion and retrieval techniques.
Related Literature
The linked study describes a case where the Gunther Tulip Vena Cava MReye Filter Retrieval Set was used to successfully retrieve a dislodged paclitaxel-eluting coronary stent from the abdominal aorta. The study highlights the device's unique curve loop design, which facilitated the retrieval. While the study provides a successful case example, it is limited by its single-case nature and may not be generalizable.
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 is the Gunther Tulip Vena Cava MReye Filter Set used for?
It is used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava, especially in patients who cannot take anticoagulants.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for preventing recurrent pulmonary embolism in high-risk patients where anticoagulation is contraindicated or ineffective.
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.