option elite vena cava filter system 352506070e 352506100e
Argon Medical Devices
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.
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.
Clinical Applications
This device is commonly used in clinical scenarios where patients are at risk of pulmonary embolism and cannot undergo anticoagulation therapy. It is also used in cases where anticoagulation has been ineffective.
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.
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.
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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