Arox 45-jbp Arox 53-jbp Merox 45-jbp Merox 53-jbp
FDA Clearance Information
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
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients with contraindications to anticoagulation therapy.
- Prevention of recurrent pulmonary embolism in patients who have experienced embolism despite anticoagulation therapy.
Clinical Applications
- Placement in the inferior vena cava to help prevent pulmonary embolism.
- Use in patients who cannot receive anticoagulant medication because of bleeding or another contraindication.
- Use in patients with recurrent pulmonary embolism despite anticoagulation therapy.
- Image-guided placement through a venous access site, such as the jugular or femoral vein.
Reported off-label uses
- Prevention of pulmonary embolism in selected patients with a high risk of venous thromboembolism who do not meet the labeled indications; this use requires individualized specialist assessment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The 45-jbp and 53-jbp models provide different filter sizes; the appropriate model depends on the patient's IVC anatomy and the device's instructions for use.
- Placement requires fluoroscopic or other appropriate imaging guidance and careful positioning within the IVC.
- The device should not be used when an IVC filter is contraindicated, such as with unsuitable IVC anatomy, active infection at the access or implant site, or allergy to device materials or contrast when no alternative is available.
- The FDA record supplied does not establish MRI safety. MRI conditions should be confirmed in the current manufacturer labeling before scanning.
- Whether the filter is intended to remain permanently or can be retrieved must be confirmed in the current device labeling; follow-up is important because filters may thrombose, migrate, tilt, fracture, or perforate the vena cava.
Procedures that use this device
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.