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Biotronik
Summary: The arox series by Biotronik includes IVC filters used to prevent pulmonary embolism. These devices are typically used by interventional radiologists and vascular surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K021217 ↗
Decision Date
May 1, 2002
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The arox series received FDA clearance via the 510k pathway on May 1, 2002. Manufactured by Biotronik, these devices are classified as Class III medical devices.
What It Is
The arox series comprises inferior vena cava (IVC) filters designed to prevent blood clots from traveling to the lungs, reducing the risk of pulmonary embolism. These filters are implanted in the IVC, the large vein carrying blood from the lower body to the heart. They work by catching clots while allowing normal blood flow, providing a mechanical barrier against emboli.
Clinical Applications
IVC filters like the arox series are commonly used in patients who have a high risk of developing pulmonary embolism but cannot be managed with anticoagulation therapy. They are often used in trauma patients, those with contraindications to anticoagulation, and patients with recurrent venous thromboembolism despite anticoagulation. These devices are typically deployed in interventional radiology suites or operating rooms.
Indications for Use
The FDA indications for the arox series include preventing pulmonary embolism in patients who are at risk and cannot use anticoagulants. This includes patients with a history of deep vein thrombosis or those undergoing major surgeries.
Practical Considerations
The arox series comes in various sizes to accommodate different patient anatomies. Compatibility with imaging modalities is crucial for accurate placement. Clinicians should be familiar with the insertion technique and potential complications such as migration or filter fracture.
Frequently Asked Questions
What is arox used for?
The arox series 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 IVC filters like the arox series.
What are the FDA-cleared indications?
The arox series is indicated for preventing pulmonary embolism in patients at risk who cannot use 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.