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Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator Models 466-p306au 466-p306bu
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 ?
510(k)
Number ?
K020316 ↗
Decision Date ?
March 20, 2002
Product Code ?
DQO Catheter, Intravascular, Diagnostic
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.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for embolic disease.
- Use in patients with contraindications to anticoagulation therapy.
- Use in patients with recurrent pulmonary embolism despite adequate anticoagulation.
Clinical Applications
- Permanent IVC filter placement for pulmonary embolism prevention.
- Placement in patients who cannot receive anticoagulant medication.
- Placement in patients who develop recurrent emboli despite anticoagulation.
Reported off-label uses
- Temporary protection from pulmonary embolism when a retrievable filter is unavailable or unsuitable; this is not the labeled permanent-use indication and requires individualized clinical judgment.
- Use for selected patients with free-floating or large lower-extremity or iliocaval thrombus; evidence and clinical practice vary.
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 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.
Practical Considerations
- The Trapease filter is intended for permanent implantation and is not designed for routine retrieval.
- Placement is generally performed through venous access, commonly the jugular or femoral vein, using fluoroscopic imaging; the listed Visease angiographic vessel dilator models 466-P306AU and 466-P306BU are associated delivery-system components.
- The appropriate filter and delivery-system size must match the patient's IVC diameter and the labeled device specifications.
- Review the current manufacturer instructions for MRI conditions, because MRI safety depends on the exact implanted device and labeling; do not assume that an older permanent filter is automatically MRI safe.
- Potential complications include access-site bleeding, filter migration or tilt, caval thrombosis or perforation, recurrent pulmonary embolism, and long-term device-related complications.
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 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.
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.