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celect platinum vena cava filter set for femoral vein approach igtcfs-65-1-fem-celect-pt celect platinum vena cava filter set for jugular vein approach igtcfs-65-1-jug-celect-pt celect platinum vena cava filter set for femoral and jugular vein approach igtcfs-65-1-uni-celect-pt gunther tulip vena cava filter set for femoral vein approach igtcfs-65-1-fem-tulip gunther tulip vena cava filter set for jugular vein approach igtcfs-65-1-jug-tulip gunther tulip vena cava filter

William Cook Europe Aps

Summary: The Celect Platinum and Gunther Tulip Vena Cava Filters are devices used for preventing pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence highlights their efficacy in retrieval and management of complex cases.

FDA Clearance Information

Pathway 510K
Number K233680 ↗
Decision Date January 18, 2024
Product Code DTK
Device Class Class 2
Evidence 11 studies

The Celect Platinum and Gunther Tulip Vena Cava Filters were cleared via the FDA 510k pathway on January 18, 2024. Manufactured by William Cook Europe Aps, they are classified as Class 2 medical devices.

What It Is

The Celect Platinum and Gunther Tulip Vena Cava Filters are intravascular devices designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. They are intended for temporary or permanent placement, with options for retrieval.

Clinical Applications

These filters are commonly used in patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy. They are also employed in cases of recurrent embolism despite anticoagulation.

Evidence Summary

The available literature includes a mix of RCTs, prospective and retrospective studies, and case series, with a total of 10 studies spanning from 2019 to 2025. These studies focus on retrieval techniques and safety outcomes.

Reported Outcomes

Published studies report successful retrieval of IVC filters using advanced techniques, with outcomes indicating effective prevention of pulmonary embolism. A prospective database study highlighted the importance of active patient management in retrieval success.

Safety Profile

Reported complications include difficulties in filter retrieval, with some cases requiring advanced techniques. A retrospective review indicated the safety of continuing anticoagulation during retrieval.

Evidence Limitations

Evidence gaps include a lack of large-scale RCTs directly comparing different filter types. Further research is needed to optimize retrieval techniques and long-term outcomes.

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 Celect Platinum & Gunther Tulip Vena Cava Filters?

These filters are indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy or have recurrent embolism despite anticoagulation.

What outcomes have been reported in clinical studies?

Clinical studies have reported successful retrieval of filters and effective prevention of pulmonary embolism, with active patient management improving retrieval outcomes.

What complications have been reported?

Safety data indicate complications in filter retrieval, necessitating advanced techniques in some cases. Continuing anticoagulation during retrieval has been deemed safe in retrospective reviews.

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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