ClearPoint Neuro Label Indications

 

Last Modified: April 23, 2021

FDA Cleared Labeling:

The ClearPoint^® System:

The ClearPoint^® System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

The SmartFlow^® Cannula

The SmartFlow® MR Compatible Ventricular Cannula has received 510(k) clearance from the FDA for use in the US for the aspiration of CSF or injection of the chemotherapy drug, Cytarabine, into the ventricle.

CE Mark Labeling:

The ClearPoint^® System:

The ClearPoint^® System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter, and electrode insertion. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

The SmartFlow^® Cannula:

The SmartFlow^® MR Compatible Ventricular Cannula has received CE Mark for use in Europe for the delivery of approved fluids in the brain or aspiration of CSF.  The SmartFlow Cannula is also being used in approved clinical and pre-clinical studies for various research and drug trials.