đź“Š Evidence-Based Reference
Option Elite Vena Cava Filter System
Rex Medical, L.P.
Summary: The Option Elite Vena Cava Filter System is a device used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. Key evidence highlights its retrievability and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133243 ↗
Decision Date ?
December 17, 2013
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
5 studies
The Option Elite Vena Cava Filter System was cleared by the FDA through the 510(k) pathway on December 17, 2013. It is manufactured by Rex Medical, L.P. and classified as a Class 2 medical device.
What It Is
The Option Elite Vena Cava Filter System is a retrievable filter designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. It is intended for use in patients with contraindications to anticoagulation therapy.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for thromboembolic disease.
- Use in patients who have contraindications to anticoagulation therapy.
- Use when anticoagulant therapy has failed, according to the device labeling.
Clinical Applications
- Percutaneous placement of a retrievable filter in the inferior vena cava.
- Protection from pulmonary embolism in patients with venous thromboembolism who cannot receive anticoagulation.
- Temporary IVC filtration when protection is needed during a period of increased thromboembolic risk.
- Filter retrieval when protection is no longer clinically necessary and retrieval is appropriate.
Reported off-label uses
- Use for selected patients with recurrent pulmonary embolism despite therapeutic anticoagulation.
- Use for temporary protection in selected patients with a high risk of venous thromboembolism when anticoagulation is temporarily interrupted.
- Placement above the renal veins or in other nonstandard locations in selected anatomic circumstances.
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 literature includes 11 studies, comprising case reports, retrospective analyses, and prospective studies, with publication years ranging from 2022 to 2024. These studies explore retrieval techniques, safety, and cost comparisons.
Reported Outcomes
Published studies report successful retrieval of the Option Elite filter in various clinical scenarios, including challenging cases with embedded filters. Outcomes include effective prevention of pulmonary embolism and successful retrieval without significant complications.
Safety Profile
Reported complications include patient discomfort such as chest pain and palpitations during retrieval, which resolved post-procedure. No significant adverse events like contrast medium extravasation, pericardial tamponade, or pleural effusion were noted.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some reports. Further research is needed to evaluate long-term outcomes and compare efficacy with other filter systems.
Practical Considerations
- The filter is delivered through a catheter, commonly through femoral or jugular venous access, and positioned under fluoroscopic imaging in the IVC.
- Available filter and delivery-system sizes, access requirements, and placement limitations should be confirmed in the current manufacturer instructions for use.
- The filter is retrievable, but retrieval may become more difficult or may not be possible if it remains implanted for an extended period, becomes tilted, is embedded, or develops substantial thrombus.
- MRI conditions should be confirmed in the current labeling before scanning; the exact model, implant status, and MRI field conditions matter.
- Potential complications include access-site bleeding, filter migration or tilting, vena cava perforation, thrombosis, filter fracture, recurrent embolism, and complications related to retrieval.
Procedures that use this device
Linked Studies (5)
PubMed • 2024
Case Report: Endoluminal removal of a conical retrievable superior vena cava filter with a retraction hook attached to the wall.
Frontiers in cardiovascular medicine
Case Series View Source →PubMed • 2022
Over-the-wire deployment techniques of option elite inferior vena cava filter: 3D printing vena cava phantom study.
European journal of radiology open
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2018
Retrieval characteristics of the Bard Denali and Argon Option inferior vena cava filters.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Filter Eversion Technique for Removal of Option ELITE Inferior Vena Cava Filters.
Journal of vascular and interventional radiology : JVIR
View Source →PubMed • 2017
Transfemoral Filter Eversion Technique following Unsuccessful Retrieval of Option Inferior Vena Cava Filters: A Single Center Experience.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Option Elite Vena Cava Filter System?
The device is indicated for patients at risk of pulmonary embolism who have contraindications to anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report successful retrieval and prevention of pulmonary embolism, with effective filter deployment and retrieval techniques.
What complications have been reported?
Safety data indicate minor complications such as transient chest pain during retrieval, with no major adverse events reported.
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.