Modification to Medamicus Axia Rsn
Medamicus
FDA Clearance Information
The device was cleared through the FDA 510(k) pathway on August 23, 2002, by Medamicus. It is classified as a Class 2 medical device under product code DYB.
What It Is
FDA-Cleared Indications
- Use in embolization procedures to occlude selected blood vessels.
- Treatment of vascular abnormalities that require catheter-based vessel occlusion.
Clinical Applications
- Embolization of selected abnormal blood vessels.
- Catheter-based treatment of aneurysms requiring vessel occlusion.
- Embolization of arteriovenous malformations requiring blockage of abnormal blood flow.
Reported off-label uses
- Coil embolization of selected bleeding arteries, such as gastrointestinal or bronchial arteries, may be performed in clinical practice depending on the device labeling, anatomy, and physician judgment.
- Embolization of selected pelvic or visceral vessels may be performed for conditions such as varicocele, uterine bleeding, or organ-directed procedures, but these uses should not be assumed to be specifically cleared for this device.
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 coil is delivered through a compatible catheter under fluoroscopic or other appropriate imaging guidance; the treating specialist selects the coil and catheter size based on vessel anatomy.
- Available sizes and delivery-system compatibility should be confirmed in the current manufacturer instructions for use before the procedure.
- Potential risks include non-target embolization, vessel injury, bleeding, infection, ischemia, device migration, and incomplete or recurrent occlusion.
- MRI safety and conditional-use information must be confirmed in the current device labeling; do not assume that an embolization coil is MR safe without that documentation.
- Use may be inappropriate in patients with an unsafe vascular access route, uncontrolled infection, severe contrast allergy that cannot be managed, or anatomy that does not permit safe catheter and coil placement.
Procedures that use this device
Frequently Asked Questions
What is the Modification to Medamicus Axia RSN used for?
It is used for embolization procedures to occlude blood vessels in conditions like aneurysms and arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists primarily use this device in hospital settings, particularly in radiology departments or catheterization labs.
What are the FDA-cleared indications?
The device is indicated for embolization procedures to treat vascular abnormalities such as aneurysms and arteriovenous malformations.