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gunther tulip vena cava filter cook celect vena cava filter

William Cook Europe Aps

Summary: The Gunther Tulip Vena Cava Filter is a retrievable 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 K090140 ↗
Decision Date April 3, 2009
Product Code DTK
Device Class Class 2
Evidence 11 studies

The Gunther Tulip Vena Cava Filter was cleared by the FDA through the 510(k) pathway on April 3, 2009. It is manufactured by William Cook Europe Aps and classified as a Class 2 medical device.

What It Is

The Gunther Tulip Vena Cava Filter is a medical device designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. It is intended for temporary or permanent placement and can be retrieved when no longer needed.

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 high-risk surgical procedures.

Evidence Summary

The available literature includes 11 studies, encompassing various study designs such as case series and retrospective analyses. These studies were published between 2011 and 2020, providing insights into the device's performance and safety.

Reported Outcomes

Published studies report that the Gunther Tulip Vena Cava Filter is effective in preventing pulmonary embolism. Midterm outcomes indicate satisfactory filter integrity and efficacy. Successful retrieval has been documented even in challenging cases involving filter migration or embedding.

Safety Profile

Reported complications include filter migration, perforation of the vena cava wall, and difficulty in retrieval due to thrombus formation or embedding in the vena cava wall. These events highlight the importance of careful patient selection and monitoring.

Evidence Limitations

The evidence is limited by the predominance of retrospective and case series studies, which may introduce bias. Further research is needed to evaluate long-term outcomes and optimize retrieval techniques.

Linked Studies (11)

PubMed • 2025

Two-Year Outcomes from the Cook Inferior Vena Cava Filter (CIVC) Study.

Journal of vascular and interventional radiology : JVIR

Prospective View Source →
PubMed • 2023

Management of failed inferior vena cava filter retrieval for complex cases: A case series.

Journal of clinical imaging science

View Source →
PubMed • 2022

Filter tilting and retrievability of the Celect and Denali inferior vena cava filters using propensity score-matching analysis.

European journal of radiology open

RCT|prospective|retrospective|case Series|other View Source →
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 • 2018

Complications and retrieval characteristics of Celect Platinum inferior vena cava filters.

Journal of vascular surgery. Venous and lymphatic disorders

Retrospective 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 • 2009

Initial experience in 115 patients with the retrievable Cook Celect vena cava filter.

Journal of medical imaging and radiation oncology

Retrospective View Source →
PubMed • 2009

Deployment performance and retrievability of the Cook Celect vena cava filter.

Journal of vascular and interventional radiology : JVIR

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

Celect Vena Cava Filter Clinical Trial

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, particularly those who cannot undergo anticoagulation therapy or have recurrent embolism despite treatment.

What outcomes have been reported in clinical studies?

Studies report effective prevention of pulmonary embolism, with satisfactory midterm filter integrity and successful retrieval in challenging scenarios.

What complications have been reported?

Safety data indicate complications such as filter migration, vena cava wall perforation, and retrieval difficulties due to thrombus or embedding.

Related Device Categories

IVC Filters
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.

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