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option vena cava filter
Rex Medical
Summary: The Option Vena Cava Filter by Rex Medical is a device used to prevent pulmonary embolism by capturing blood clots. It is FDA 510k cleared and supported by 13 studies, highlighting its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K081410 ↗
Decision Date
June 4, 2009
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The Option Vena Cava Filter received FDA clearance through the 510k pathway on June 4, 2009. It is manufactured by Rex Medical and classified as a Class 2 medical device.
What It Is
The Option Vena Cava Filter is a medical device designed to prevent pulmonary embolism by capturing thrombi in the inferior vena cava. It is intended for use in patients at risk of venous thromboembolism who cannot undergo anticoagulation therapy.
Clinical Applications
This device is commonly used in clinical scenarios where patients are at risk of pulmonary embolism and anticoagulation therapy is contraindicated. It is particularly relevant in cases of deep vein thrombosis and during certain surgical procedures.
Evidence Summary
The literature includes 13 studies, comprising RCTs, prospective, retrospective, and case series, conducted between 2022 and 2024. These studies evaluate the device's characteristics, deployment techniques, and clinical outcomes.
Reported Outcomes
Published studies report that the Option Vena Cava Filter effectively prevents pulmonary embolism in patients at risk. The device's deployment techniques have been studied for optimal placement, and its efficacy in capturing thrombi has been demonstrated in various clinical settings.
Safety Profile
Reported complications include filter tilt and migration, which have been observed during deployment. Some studies also note the potential for filter fracture and vena cava perforation, though these events are relatively rare.
Evidence Limitations
The evidence base is limited by the variability in study design and the relatively small sample sizes in some studies. Further research is needed to establish long-term outcomes and to optimize deployment techniques.
Frequently Asked Questions
What are the clinical indications for Option Vena Cava Filter?
The Option Vena Cava Filter is indicated for patients at risk of pulmonary embolism who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies have reported effective prevention of pulmonary embolism and successful thrombus capture with the Option Vena Cava Filter.
What complications have been reported?
Safety data indicate complications such as filter tilt, migration, fracture, and vena cava perforation.
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.