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cordis trapease permanent vena cava filter with the visease angiographic vessel dilator models 466-p306au 466-p306bu

Cordis

Summary: The Cordis Trapease Permanent Vena Cava Filter is designed for permanent implantation to prevent pulmonary embolism. Key evidence highlights its efficacy in preventing clinical PE with minimal complications.

FDA Clearance Information

Pathway 510K
Number K020316 ↗
Decision Date March 20, 2002
Product Code DQO
Device Class Class 2
Evidence 13 studies

The Cordis Trapease Permanent Vena Cava Filter was cleared by the FDA via the 510(k) pathway on March 20, 2002. It is manufactured by Cordis and classified as a Class 2 medical device.

What It Is

The Cordis Trapease Permanent Vena Cava Filter is a medical device intended for permanent implantation in the inferior vena cava to prevent pulmonary embolism. It functions by trapping emboli that may travel from the lower extremities to the lungs.

Clinical Applications

This device is commonly used in patients who are at risk of pulmonary embolism and have contraindications to anticoagulation therapy. It is also used in patients with recurrent embolism despite anticoagulation.

Evidence Summary

The available literature includes a mix of retrospective studies and case reports, with a total of 5 studies reviewed. The studies span from 2001 to 2018, providing insights into long-term efficacy and safety.

Reported Outcomes

Published studies report that the Cordis Trapease filter effectively prevents clinical pulmonary embolism, with no cases of filter migration or fracture observed. Radiologic signs of segmental PE were noted in a small subset of patients.

Safety Profile

Reported complications include asymptomatic total cava thrombosis in one case. Long-term complications such as IVC occlusion and perforation are noted but require further imaging follow-up for accurate incidence assessment.

Evidence Limitations

The evidence is limited by a lack of long-term imaging follow-up and reliance on retrospective data. Further prospective studies are needed to assess long-term safety and efficacy comprehensively.

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 Cordis Trapease Permanent Vena Cava Filter?

The device is indicated for patients at risk of pulmonary embolism, particularly those with contraindications to anticoagulation therapy or recurrent embolism despite anticoagulation.

What outcomes have been reported in clinical studies?

Studies report effective prevention of clinical pulmonary embolism, with no filter migration or fracture observed.

What complications have been reported?

Safety data indicate complications such as asymptomatic total cava thrombosis and potential long-term issues like IVC occlusion and perforation.

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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