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trapease permanent vena cava filter and introduction kit model 466-p306a

Cordis

Summary: The TrapEase Permanent Vena Cava Filter by Cordis is designed to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. Key evidence highlights its efficacy and safety over long-term use.

FDA Clearance Information

Pathway 510K
Number K010083 ↗
Decision Date June 6, 2001
Product Code DTK
Device Class Class 2
Evidence 13 studies

The TrapEase filter was cleared by the FDA through the 510(k) pathway on June 6, 2001. It is manufactured by Cordis and classified as a Class 2 medical device.

What It Is

The TrapEase Permanent Vena Cava Filter is a medical device implanted in the inferior vena cava to prevent pulmonary embolism by capturing emboli. It is intended for 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 provides mechanical protection against pulmonary embolism.

Evidence Summary

The literature includes retrospective studies, case series, and reports, with approximately 10 studies published between 2009 and 2019. These studies assess the safety, efficacy, and retrieval techniques of the TrapEase filter.

Reported Outcomes

Published studies report that the TrapEase filter is effective in preventing pulmonary embolism. Long-term use has been associated with successful prevention of embolic events. Some studies also explore retrieval techniques for the filter.

Safety Profile

Reported complications include deep venous thrombosis, filter migration, filter fracture, and caval thrombosis. These adverse events highlight the importance of careful patient selection and monitoring.

Evidence Limitations

Evidence gaps include a lack of large-scale randomized controlled trials. Most studies are retrospective or case series, which may limit the generalizability of findings. Further research is needed to optimize patient selection and management.

Linked Studies (13)

PubMed • 2019

Outcomes of the TrapEase inferior vena cava filter over 10 years at a single health care system.

Journal of vascular surgery. Venous and lymphatic disorders

Retrospective View Source →
PubMed • 2017

Percutaneous Retrieval of Permanent Inferior Vena Cava Filters.

Cardiovascular and interventional radiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2017

Double Barrel In Situ Recanalization of Thrombosed Nonretrievable IVC filter.

Annals of vascular surgery

View Source →
PubMed • 2016

Retrieval of TRAPEASE and OPTEASE Inferior Vena Cava Filters with Extended Dwell Times.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2016

Tips and tricks for retrieval of permanent TRAPEASE filters for inferior vena cava.

Vascular

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2014

Endovascular removal of a permanent "TrapEase" inferior vena cava filter.

Vascular and endovascular surgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2012

Endovascular retrieval of a TrapEase permanent inferior vena cava filter from the aorta.

Journal of vascular surgery

Case Series View Source →
PubMed • 2009

OptEase and TrapEase vena cava filters: a single-center experience in 258 patients.

Cardiovascular and interventional radiology

Retrospective View Source →
PubMed • 2005

The mid-term efficacy and safety of a permanent nitinol IVC filter(TrapEase).

Korean journal of radiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2003

Vena cava filter behavior and endovascular response: an experimental in vivo study.

Cardiovascular and interventional radiology

Other View Source →
PubMed • 2003

Preliminary results of the new 6F TrapEase inferior vena cava filter.

Annals of vascular surgery

Retrospective View Source →
PubMed • 2002

Technique for retrieval of a guidewire lodged in a vena cava filter.

Vascular and endovascular surgery

Other View Source →
PubMed • 2001

The 6-F nitinol TrapEase inferior vena cava filter: results of a prospective multicenter trial.

Journal of vascular and interventional radiology : JVIR

Prospective View Source →

Frequently Asked Questions

What are the clinical indications for TrapEase Permanent Vena Cava Filter?

The TrapEase filter is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy or have recurrent embolic events.

What outcomes have been reported in clinical studies?

Studies report effective prevention of pulmonary embolism and successful long-term use of the TrapEase filter.

What complications have been reported?

Safety data indicate complications such as deep venous thrombosis, filter migration, filter fracture, and caval thrombosis.

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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