ClearPoint Neuro Label Indications

Last Modified: April 23, 2025

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 ClearPoint^® Navigation System v.3.0:

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 an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization, and quantification of segmentable brain structures from a set of loaded MR images. 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) (asleep or awake) lead placement. When used in an MRI environment, the system is intended for use only with 1.5 and 3.0 Tesla MRI scanners and MR Conditional implants and devices.

The SmartFlow^® Cannula:

The SmartFlow Neuro Cannula has received 510(k) clearance from the FDA for use in the US for the aspiration of CSF, injection of the chemotherapy drug Cytarabine into the ventricles, or delivery of the gene therapy KEBILIDI to the brain parenchyma. This device is not intended for implant and is single patient use.

The ClearPoint Prism^® Neuro Laser Therapy System:

The ClearPoint Prism Neuro Laser Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery, for a wavelength of 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the ClearPoint Prism Neuro Laser Therapy System can process images using proton resonance frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

The ClearPoint Prism Neuro Laser Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of analysis using the ClearPoint Prism Neuro Laser Therapy System.

The SmartFrame OR^™ Stereotactic System:

The SmartFrame OR Stereotactic System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction, including the placement of deep brain stimulation (DBS) leads.

The ClearPointer^™ Optical Navigation Wand:

The ClearPointer Optical Navigation Wand is intended to be used in conjunction with the SmartFrame OR Stereotactic System and a compatible optical stereotaxic navigation system for patient registration and navigation.

The ClearPoint Bone Screw Fiducials:

The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

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 into the brain during intracranial procedures, or aspiration of CSF with the 14ga cannulas. This device is not intended for implant and is single patient use.