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cordis optease permanent vena cava filter models 466-f200a 466-f200b
Cordis
Summary: The Cordis Optease Permanent Vena Cava Filter is a device used to prevent pulmonary embolism by trapping blood clots. Key evidence highlights long-term complications and retrieval challenges.
FDA Clearance Information
Pathway 510K
Number K023116 ↗
Decision Date October 18, 2002
Product Code DTK
Device Class Class 2
Evidence 15 studies
The Cordis Optease Permanent Vena Cava Filter was cleared via the FDA 510(k) pathway on October 18, 2002. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Cordis Optease Permanent Vena Cava Filter is designed to capture thrombi in the inferior vena cava, preventing them from reaching the pulmonary arteries. It is intended for patients at risk of pulmonary embolism, especially those with contraindications to anticoagulation.
Clinical Applications
This device is commonly used in patients with venous thromboembolism who cannot undergo anticoagulation therapy. It is also used in cases of recurrent pulmonary embolism despite anticoagulation.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as retrospective and prospective analyses, published between 2009 and 2018. These studies evaluate the efficacy, safety, and complications of the device.
Reported Outcomes
Published studies report that the Cordis Optease filter effectively prevents pulmonary embolism in high-risk patients. However, retrieval can be challenging after prolonged indwelling times, requiring unconventional techniques. The device has been shown to be effective in specific clinical scenarios, such as during term pregnancy.
Safety Profile
Reported complications include filter fracture, inferior vena cava occlusion, and perforation, particularly with long-term use. Difficulties in retrieval after extended indwelling times have also been documented.
Evidence Limitations
The evidence is limited by the lack of long-term imaging follow-up and reliance on mathematical projections for complication rates. Further research is needed to assess long-term safety and efficacy in diverse patient populations.
Linked Studies (15)
PubMed • 2023
Endovascular retrieval of a fractured Optease inferior vena cava filter using endobronchial forceps and intraoperative cone-beam computed tomography guidance.
Journal of vascular surgery cases and innovative techniques
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2016
The use of optional inferior vena cava filters of type Optease in trauma patients--a single type of filter in a single Medical Center.
Thrombosis research
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2016
Troubleshooting OptEase inferior vena cava filter retrieval.
Asian cardiovascular & thoracic annals
RCT|prospective|retrospective|case Series|other 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 • 2014
Difficult OptEase filter retrievals after prolonged indwelling times.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2011
Optease vena cava filter optimal indwelling time and retrievability.
Cardiovascular and interventional radiology
View Source → PubMed • 2011
Long-term safety and effectiveness of the "OptEase" vena cava filter.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2010
Update on vena cava filters.
Current treatment options in cardiovascular medicine
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2009
Histology of tissue adherent to OptEase inferior vena cava filters regarding indwelling time.
Cardiovascular and interventional radiology
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 • 2008
Long-term retrievability of IVC filters: should we abandon permanent devices?
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2008
Form and function of vena cava filters: how do optional filters measure up?
Vascular
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2006
The Jonas study: evaluation of the retrievability of the Cordis OptEase inferior vena cava filter.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source → PubMed • 2006
OptEase retrievable inferior vena cava filter: initial multicenter experience.
Vascular
View Source → ClinicalTrials.gov
Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)
View Source →Frequently Asked Questions
What are the clinical indications for Cordis Optease Permanent Vena Cava Filter?
The filter is indicated for patients at risk of pulmonary embolism who have contraindications to anticoagulation or have experienced recurrent embolism despite treatment.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, with challenges in retrieval after prolonged use.
What complications have been reported?
Complications include filter fracture, IVC occlusion, perforation, and retrieval difficulties after long indwelling times.
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.