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cordis trapease permanent vena cava filter and introduction kit
Cordis
Summary: The Cordis Trapease Permanent Vena Cava Filter is a device used to prevent pulmonary embolism by trapping blood clots. Key evidence highlights its efficacy in preventing clinical PE with minimal migration or fracture incidents.
FDA Clearance Information
Pathway 510K
Number K000062 ↗
Decision Date July 7, 2000
Product Code DTK
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 July 7, 2000. 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 designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for permanent implantation and is used in patients with contraindications to anticoagulation therapy.
Clinical Applications
This device is commonly used in patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy. It is also used in cases where there is a history of recurrent embolism despite anticoagulation.
Evidence Summary
The available literature includes a mix of retrospective studies and case reports, with a total of 5 studies published between 2001 and 2018. These studies provide insights into the long-term efficacy and safety of the device.
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 have been noted, though these are often projected due to limited long-term imaging follow-up.
Evidence Limitations
The evidence is limited by the retrospective nature of most studies and the lack of long-term imaging follow-up. Further research is needed to better understand the long-term safety profile and potential complications of the 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 who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report effective prevention of clinical pulmonary embolism with no filter migration or fracture.
What complications have been reported?
Safety data indicate rare cases of asymptomatic total cava thrombosis and potential long-term complications like IVC occlusion.
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.