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option tm elite vena cava filter 100cm system
Rex Medical, L.P.
Summary: The Option TM Elite Vena Cava Filter is a medical device used to prevent pulmonary embolism by trapping blood clots in the inferior vena cava. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K143405 ↗
Decision Date
April 16, 2015
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Option TM Elite Vena Cava Filter was cleared via the FDA 510(k) pathway on April 16, 2015. Manufactured by Rex Medical, it is a Class 2 device under product code DTK.
What It Is
The Option TM Elite Vena Cava Filter is a device designed to be implanted in the inferior vena cava (IVC) to capture blood clots and prevent them from reaching the lungs, thereby reducing the risk of pulmonary embolism. It consists of a metal framework that expands to fit the vessel and is typically inserted via a catheter. The filter can be either permanent or retrievable, depending on the patient's needs.
Clinical Applications
This device is commonly used in patients who are at high risk for pulmonary embolism and cannot be managed with anticoagulation therapy alone. It is frequently used in hospital settings, particularly in interventional radiology and vascular surgery departments. Patients with deep vein thrombosis or those undergoing major surgeries who are at risk of clot formation are typical candidates.
Indications for Use
The FDA indications for this device include preventing pulmonary embolism in patients with a history of venous thromboembolism or those who are at high risk and cannot take blood thinners. It is suitable for patients with contraindications to anticoagulation therapy.
Practical Considerations
The filter is typically available in a 100cm delivery system, making it compatible with standard IVC sizes. Clinicians should consider the patient's anatomy and the potential need for future retrieval when selecting this device. Proper imaging and technique are crucial for successful placement.
Frequently Asked Questions
What is Option TM Elite Vena Cava Filter used for?
It is used to prevent pulmonary embolism by capturing blood clots in the inferior vena cava.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for patients at risk of pulmonary embolism who cannot take anticoagulants.
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.