đź“Š Evidence-Based Reference
Option Elite Vena Cava Filter System 352506070e 352506100e
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 retrieval success and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242612 ↗
Decision Date ?
September 10, 2024
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
5 studies
The Option Elite Vena Cava Filter System is cleared by the FDA through the 510(k) pathway on September 10, 2024. It is manufactured by Argon Medical Devices and classified as a Class 2 medical device.
What It Is
The Option Elite Vena Cava Filter System is designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. It is intended for use in patients with contraindications to anticoagulation or those who have failed anticoagulation therapy.
FDA-Cleared Indications
- Prevention of pulmonary embolism by capturing thrombi in the inferior vena cava.
- Use in patients with contraindications to anticoagulation therapy.
- Use when anticoagulation therapy has failed or is inadequate.
Clinical Applications
- Temporary IVC filtration for patients at risk of pulmonary embolism who cannot receive anticoagulant medication.
- IVC filtration for patients who remain at risk of pulmonary embolism despite anticoagulation therapy.
- Placement in the inferior vena cava using image-guided endovascular techniques.
- Retrieval when the risk of pulmonary embolism has decreased and anticoagulation or other treatment can be used, when clinically appropriate.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials, case series, and retrospective analyses, conducted between 2022 and 2024. These studies evaluate the device's retrieval success, safety, and cost-effectiveness.
Reported Outcomes
Published studies report successful retrieval of the Option Elite filter, with one case series documenting retrieval after 155 days. The device has been associated with effective prevention of pulmonary embolism in patients with contraindications to anticoagulation.
Safety Profile
Reported complications include chest pain and palpitations during retrieval, which resolved post-procedure. No major adverse events such as contrast medium extravasation, pericardial tamponade, or pleural effusion were noted in the studies.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to assess the long-term safety and efficacy of the device, as well as its performance in diverse patient populations.
Practical Considerations
- The system includes 28 mm and 32 mm filter options, with product configurations identified by model numbers 352506070E and 352506100E.
- Placement and retrieval require venous access and imaging guidance, commonly through the jugular or femoral vein, with filter sizing based on the IVC diameter.
- The device is intended for the inferior vena cava and should not be placed in vessels outside the labeled anatomy.
- MRI conditions should be confirmed in the current manufacturer instructions for use before scanning; patients should provide the exact filter model to the MRI team.
- Potential complications include filter migration, tilting, fracture, perforation, thrombosis, access-site bleeding and difficulty with retrieval. Retrieval timing should be assessed individually because prolonged dwell time can make removal more difficult.
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 cannot undergo anticoagulation therapy or have failed anticoagulation.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful retrieval of the filter and effective prevention of pulmonary embolism in indicated patients.
What complications have been reported?
Safety data indicate minor complications such as 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.