📊 Evidence-Based Reference

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

William Cook Europe Aps

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 510K

Number K172557 ↗

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 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.

Clinical Applications

This device is commonly used in patients at risk of pulmonary embolism, particularly those with contraindications to anticoagulation therapy or recurrent embolism despite anticoagulation. It is also used in trauma patients and those undergoing surgery.

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.

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.