đź“Š Evidence-Based Reference
Trapease Permanent Vena Filter and Introduction Kit Models 466-p306a and 466-p306b
Summary: The TrapEase Permanent Vena Filter by Cordis is used for preventing 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 ?
510(k)
Number ?
K003964 ↗
Decision Date ?
January 19, 2001
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
13 studies
The TrapEase Permanent Vena Filter was cleared by the FDA via the 510(k) pathway on January 19, 2001. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The TrapEase Permanent Vena Filter is a medical device designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for permanent placement and is used in patients at risk of thromboembolic events.
FDA-Cleared Indications
- Prevention of pulmonary embolism by trapping thromboemboli in the inferior vena cava.
- Use in patients who require protection from pulmonary embolism when anticoagulant therapy is contraindicated, ineffective, or not tolerated.
Clinical Applications
- Permanent IVC filter placement for patients at risk of pulmonary embolism.
- Placement when anticoagulation is contraindicated or cannot be used.
- Placement when pulmonary embolism prevention is needed despite anticoagulation management.
Reported off-label uses
- Use in selected patients with recurrent pulmonary embolism despite therapeutic anticoagulation.
- Use in selected trauma or perioperative patients when clinicians judge the risk of venous thromboembolism to be high and anticoagulation is temporarily unsuitable.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes retrospective studies, case series, and reports, covering a total of approximately 10 studies from 2009 to 2019. These studies evaluate the safety, efficacy, and complications associated with the TrapEase filter.
Reported Outcomes
Published studies report that the TrapEase filter is effective in preventing pulmonary embolism. Long-term follow-up indicates a reduction in thromboembolic events in patients with the filter. However, some studies highlight challenges in filter retrieval and potential for filter migration.
Safety Profile
Reported complications include filter migration, deep venous thrombosis, and caval thrombosis. Some studies also note difficulties in retrieval of the filter, particularly when left in place for extended periods.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and small sample sizes. Further research is needed to evaluate long-term outcomes and compare the TrapEase filter with other IVC filters.
Practical Considerations
- The TrapEase is intended for permanent implantation; retrieval is not the routine intended use. Decisions about removal or management of a permanently implanted filter require specialist evaluation.
- Placement is generally performed through venous access, commonly the internal jugular or femoral vein, using fluoroscopic imaging.
- The filter is supplied in model-specific sizes and must be matched to the patient's IVC diameter and the compatible introduction system described in the device labeling.
- MRI conditions and scan limitations should be confirmed in the current manufacturer labeling before imaging. The exact MRI status should not be assumed from the device name alone.
- Potential concerns include filter migration, malposition, thrombosis or occlusion of the IVC, penetration of the caval wall, fracture, and recurrent pulmonary embolism. A filter does not treat existing venous thrombosis or replace anticoagulation when anticoagulation is appropriate.
Procedures that use this device
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 Filter?
The TrapEase filter is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism and reduced thromboembolic events, with some challenges in filter retrieval.
What complications have been reported?
Complications include filter migration, deep venous thrombosis, caval thrombosis, and difficulties in retrieval.
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.