📊 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 510K
Decision Date December 17, 2013
Product Code DTK
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.

Clinical Applications

Commonly used in patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy, the Option Elite filter is deployed in the inferior vena cava to prevent thromboembolic events.

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.

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.

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