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arox 45-jbp arox 53-jbp merox 45-jbp merox 53-jbp
Biotronik
Summary: The arox and merox 45/53-jbp devices are inferior vena cava (IVC) filters used to prevent pulmonary embolism. They are typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K023099 ↗
Decision Date
October 18, 2002
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The arox and merox 45/53-jbp devices were cleared through the FDA 510(k) pathway on October 18, 2002. Manufactured by Biotronik, these devices are classified as Class III under product code DTB.
What It Is
The arox and merox 45/53-jbp are IVC filters designed to capture blood clots that may travel from the lower extremities to the lungs, thus preventing pulmonary embolism. These devices are typically implanted in the inferior vena cava via a minimally invasive procedure, often performed under fluoroscopic guidance. They are constructed to allow blood flow while trapping emboli.
Clinical Applications
These IVC filters are commonly used in patients who are at risk for pulmonary embolism but cannot be managed with anticoagulation therapy. They are frequently utilized in trauma patients, those with contraindications to anticoagulation, or in cases of recurrent embolism despite anticoagulation. Interventional radiologists and vascular surgeons typically perform the implantation in hospital settings.
Indications for Use
The FDA-cleared indications for these devices include prevention of pulmonary embolism in patients with contraindications to anticoagulation therapy or those who have experienced recurrent embolism despite anticoagulation. They are particularly useful in patients with high risk of venous thromboembolism.
Practical Considerations
These filters come in various sizes to accommodate different patient anatomies and are compatible with standard delivery systems. Proper placement technique is crucial to ensure optimal performance and minimize complications. Clinicians should be familiar with the retrieval process if the filter is intended for temporary use.
Frequently Asked Questions
What is arox/merox 45/53-jbp used for?
These devices are 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 these devices.
What are the FDA-cleared indications?
The devices are indicated for patients at risk of pulmonary embolism who cannot use anticoagulation therapy or have recurrent embolism despite it.
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.