đź“Š Evidence-Based Reference
optease vena cava filter and retrieval catheter
Cordis Corp., A Johnson & Johnson
Summary: The Optease Vena Cava Filter is a retrievable device used to prevent pulmonary embolism. Key evidence highlights challenges in retrieval and associated complications.
FDA Clearance Information
Pathway 510K
Number K091077 ↗
Decision Date February 4, 2010
Product Code DTK
Device Class Class 2
Evidence 15 studies
The Optease Vena Cava Filter was cleared via the FDA 510(k) pathway on February 4, 2010. It is manufactured by Cordis Corp., a Johnson & Johnson company, and is classified as a Class 2 medical device.
What It Is
The Optease Vena Cava Filter is a retrievable filter designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is intended for temporary placement in patients at risk of venous thromboembolism.
Clinical Applications
Commonly used in patients who are at risk of pulmonary embolism and cannot undergo anticoagulation therapy. It is often employed in trauma patients and those with contraindications to anticoagulation.
Evidence Summary
The literature includes 11 studies, comprising various study types such as case series and retrospective analyses, published between 2016 and 2023. These studies explore retrieval techniques, complications, and clinical outcomes.
Reported Outcomes
Published studies report that the Optease Vena Cava Filter effectively prevents pulmonary embolism in high-risk patients. However, retrieval can be challenging, particularly after prolonged indwelling times. Some studies highlight the need for advanced retrieval techniques.
Safety Profile
Reported complications include filter fracture, difficult retrieval, and the development of caval pseudoaneurysms. These complications underscore the importance of timely retrieval and careful patient monitoring.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and small sample sizes. Further research is needed to optimize retrieval techniques and better understand long-term outcomes and complications.
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 Optease Vena Cava Filter?
The filter 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 pulmonary embolism, but highlight challenges in retrieval and associated complications.
What complications have been reported?
Safety data indicate complications such as filter fracture, difficult retrieval, and caval pseudoaneurysms.
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.