Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
Maduro Medical, Inc.
FDA Clearance Information
FDA-Cleared Indications
- Intended for the removal of thrombus from blood vessels.
- Used with compatible aspiration equipment during endovascular thrombus-retrieval procedures.
- The labeled indication is limited to the specific catheter sizes, accessories, anatomy, and patient population described in the FDA-cleared instructions for use.
Clinical Applications
- Aspiration-assisted removal of thrombus from a blood vessel.
- Use during endovascular mechanical thrombectomy for selected acute ischemic stroke patients when consistent with the device labeling.
- Catheter-based clot retrieval under fluoroscopic imaging and physician guidance.
- Connection to compatible aspiration tubing and collection equipment during a thrombectomy procedure.
Practical Considerations
- The product family includes 0.064-inch and 0.076-inch catheter models; the appropriate size depends on the target vessel, access system, clot location, and compatible equipment.
- Use requires compatible guide catheters, aspiration tubing, and vacuum or aspiration equipment as specified in the instructions for use.
- The catheters are advanced over or through an endovascular access system under fluoroscopic imaging; careful handling is required to reduce the risk of vessel injury, dissection, perforation, or catheter damage.
- MRI safety and conditional use should be confirmed in the current FDA-cleared labeling; do not assume the catheter or tubing kit is safe in an MRI scanner.
- Contraindications, warnings, and limitations may include inability to safely access the target vessel, unsuitable vessel anatomy, significant vascular disease, or other patient factors described in the instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Radical Reperfusion Catheter used for?
It is used with aspiration equipment to remove blood clots from vessels during an endovascular thrombectomy procedure. Its labeled use depends on the catheter model and the FDA-cleared instructions for use.
What sizes are available for the Radical Reperfusion Catheter?
The listed product family includes the Radical 064 and Radical 076 Reperfusion Catheters, referring to approximate catheter inner diameters of 0.064 and 0.076 inches. The treating physician selects the size based on vessel anatomy and compatible equipment.
Is the Radical Reperfusion Catheter MRI safe?
MRI safety status should be checked in the current manufacturer labeling. Do not bring the catheter, tubing kit, or associated accessories into an MRI environment unless they are specifically identified as MR Safe or MR Conditional.
How long does a Radical Reperfusion Catheter last?
These catheters and the aspiration tubing kit are intended for use during a procedure and are generally single-use devices. They should not be reused or resterilized unless the labeling specifically permits it.
How much does the Radical Reperfusion Catheter cost?
The price is usually not publicly standardized and may vary by hospital, distributor, contract, and product configuration. A hospital or supplier must provide the current device and procedure-related cost.