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Cordis Optease Vena Cava Filter Models 466-f220a and 466-f220b Retrievable Catheter Model 466-c220f
Summary: The Cordis Optease Vena Cava Filter is a retrievable device used to prevent pulmonary embolism. Key evidence highlights its efficacy in preventing embolic events during catheter-directed thrombectomy and challenges in retrieval after prolonged indwelling times.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K034050 ↗
Decision Date ?
March 22, 2004
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
15 studies
The Cordis Optease Vena Cava Filter was cleared by the FDA via the 510(k) pathway on March 22, 2004. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Cordis Optease Vena Cava Filter is a retrievable filter designed to be placed in the inferior vena cava to prevent pulmonary embolism by capturing emboli. It is intended for temporary use with the option for retrieval when the risk of embolism has subsided.
FDA-Cleared Indications
- Prevention of pulmonary embolism by trapping thromboemboli in the inferior vena cava.
- Use in patients at risk for pulmonary embolism when anticoagulation is contraindicated or ineffective.
- Temporary protection during periods of increased embolic risk, with retrieval when clinically appropriate.
Clinical Applications
- Placement in the inferior vena cava for patients at risk of pulmonary embolism.
- Temporary pulmonary embolism protection when anticoagulant treatment cannot be used or does not adequately control the risk.
- Protection during selected catheter-based treatment of deep vein thrombosis when embolic risk is a concern.
- Retrieval after the risk of pulmonary embolism has decreased, when removal is clinically appropriate.
Reported off-label uses
- Prophylactic placement in selected trauma patients without documented venous thromboembolism.
- Temporary protection in selected patients undergoing major surgery who have a high risk of venous thromboembolism and cannot receive anticoagulation.
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 11 studies ranging from randomized controlled trials to retrospective analyses. These studies, published between 2014 and 2019, explore the filter's efficacy, retrievability, and long-term safety.
Reported Outcomes
Published studies report that the Cordis Optease Vena Cava Filter is effective in preventing pulmonary embolism during high-risk procedures. However, retrieval can be challenging after prolonged indwelling times, requiring unconventional techniques.
Safety Profile
Reported complications include filter fracture, inferior vena cava occlusion, and perforation, particularly after extended dwell times. These issues highlight the importance of timely retrieval to minimize adverse events.
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 outcomes and optimize retrieval techniques.
Practical Considerations
- The listed models include Optease filters 466-F220A and 466-F220B and retrievable catheter 466-C220F; use requires the compatible delivery and retrieval system.
- Placement is generally performed through venous access, commonly the internal jugular or common femoral vein, under fluoroscopic imaging.
- The filter is intended for temporary use when appropriate; prolonged dwell time can increase tilt, embedment, fracture, migration, or difficulty with retrieval.
- Patients should be evaluated for retrieval once protection is no longer needed. Retrieval may not be possible in every case, particularly after prolonged implantation or substantial filter incorporation.
- MRI conditions should be confirmed in the current manufacturer labeling and institutional MRI safety records before scanning; device-specific field-strength and positioning requirements may apply.
Procedures that use this device
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 Vena Cava Filter?
The filter is indicated for preventing pulmonary embolism in patients at temporary risk, such as during catheter-directed thrombectomy for deep vein thrombosis.
What outcomes have been reported in clinical studies?
Studies report effective prevention of pulmonary embolism, but retrieval can be difficult after prolonged use.
What complications have been reported?
Reported complications include filter fracture, IVC occlusion, and perforation, especially with extended 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.