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optease vena cava filter and optease retrieval cathteter

Cordis, A Johnson & Johnson

Summary: The Optease Vena Cava Filter is a device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence highlights challenges in retrieval and complications such as filter migration and fracture.

FDA Clearance Information

Pathway 510K
Number K140286 ↗
Decision Date March 7, 2014
Product Code DTK
Device Class Class 2
Evidence 15 studies

The Optease Vena Cava Filter was cleared by the FDA via the 510(k) pathway on March 7, 2014. It is manufactured by Cordis, a Johnson & Johnson company, and is classified as a Class 2 medical device.

What It Is

The Optease Vena Cava Filter is a retrievable device designed to prevent pulmonary embolism by capturing emboli in the inferior vena cava. It is intended for temporary placement in patients at risk of thromboembolic events.

Clinical Applications

Commonly used in patients who are at risk of pulmonary embolism and cannot undergo anticoagulation therapy. It serves as a temporary solution to prevent emboli from reaching the lungs.

Evidence Summary

The literature includes 11 studies, comprising various study types such as RCTs, prospective, and retrospective analyses, published between 2016 and 2025. These studies explore the efficacy and safety of the Optease Vena Cava Filter.

Reported Outcomes

Published studies report that the Optease Vena Cava Filter effectively prevents pulmonary embolism in patients unable to receive anticoagulation therapy. However, retrieval can be challenging, especially after prolonged indwelling times, and may require advanced techniques.

Safety Profile

Reported complications include filter migration, fracture, and difficulty in retrieval, which can lead to caval pseudoaneurysms and vascular damage. These complications highlight the need for careful patient selection and monitoring.

Evidence Limitations

The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and optimize retrieval techniques.

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 Optease Vena Cava Filter is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.

What outcomes have been reported in clinical studies?

Clinical studies report effective prevention of pulmonary embolism, but highlight challenges in retrieval and potential complications.

What complications have been reported?

Safety data indicate complications such as filter migration, fracture, and difficult retrieval, potentially leading to vascular damage.

Related Device Categories

IVC Filters
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.

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