6: TREAT

images of NeuroBlate neurological ablation process

Thermal monitoring  – Laser actuation

  • Targeted cell damage is represented as contours (outlines) on each slice
  • Contours have 3 damage levels:
    • Yellow: Contained tissue has been exposed to the thermal equivalent of 43°C for 2 minutes duration. Tissue outside the yellow contour lines has a higher probability of receiving no thermal damage
    • Blue: Contained tissue has been exposed to the thermal equivalent of 43°C for 10 minutes duration
    • White: Contained tissue has been exposed to the thermal equivalent of 43°C for 60 minutes duration. Preclinical studies indicated that all tissue within this boundary died in ≤48 hours

5: INSERT

NeuroBlate brain imaging system

Match the software rendered probe to the actual position of the laser probe in the brain

  • The insert task is used to match the probe location in an MRI scan to where NeuroBlate® Fusion Software considers the probe to be
  • The probe void shows up in an MRI scan as a dark black line in the brain
  • Once the trajectory is confirmed, the probe’s target linear and rotary values can be changed
  • Blue is the target
  • Confirming a new target position causes the real probe to move

4: ALIGN

image of minimally invasive laser ablation software

Define the radial orientation (direction the laser exits the probe) for SideFire

  • The align task is used to define the starting point (0 degree point) of rotation where the laser exits for SideFire

3: TRAJECTORY

minimally invasive laser therapy software

Describe the entry location and anatomical target for probe insertion in the brain

  • A trajectory is essentially a line in 3D space that connects 2 points – entry point & target point

2: VOLUME

NeuroBlate brain imaging for laser ablation

Define anatomical regions of the brain

  • The volume task allows users to define anatomical areas of interest in the brain
  • Volumes are most often used to define treatment regions (e.g., tumors)
  • Can also be used to define “no-go” zones (i.e., a sensitive brain area the user does not want to ablate)

1: REGISTRATION

NeuroBlate software example

Load and fuse (co‑register) DICOM image data

  • DICOM image data is loaded in this task
  • Image data sets are co-registered (fused) together using manual or automatic settings
  • Auto and manual registration are used to match the secondary to the master

Post-Procedure:

Recovery:

  • Generally minimally invasive procedures are well tolerated and have a short recovery time.

Incision:

  • You will have 1-2 stitches to close the incision.
  • You may also have scratches on your head from the device that helps keep your head in position.

Follow-up Appointment(s):

  • You will schedule follow-up appointment(s) with your doctor as instructed.

Each patient is unique. Your doctor(s) are the best qualified to describe specifically how a procedure may affect your outlook.

Procedure:

Neuroblate laser ablation simulation showing machine

You will receive anesthesia before the procedure. Your doctor will determine what level of anesthesia is right for you. With the NeuroBlate System, doctors create a small hole in the skull, about the diameter of a pencil. While the patient is in the MRI machine, the doctor guides a small laser device (probe) through the hole into the brain lesion. The probe delivers laser light energy (laser ablation) that heats and destroys the affected tissue.

  • Because the NeuroBlate System is MRI-guided, the neurosurgeon is able to visualize the specific area of the brain to be ablated.  The precise nature of the procedure helps to lessen the likelihood of harm to nearby healthy brain tissue.1,2,3,4

Pre-Surgical Evaluation:

Prior to having brain surgery, a surgical evaluation is necessary.  The specific pre-operative tests depend on the type of surgery but may include:

  • Full health assessment
  • Evaluation of the brain lesion and the surrounding brain tissue

Your doctor will advise you of any pre-procedure requirements such as potentially stopping medications or avoiding food and drink prior to the procedure.

5. Post-Operative

NeuroBlate is a minimally invasive procedure.  Minimally invasive procedures are generally well tolerated, have a short recovery time and patients go home with 1-2 stitches.

The NeuroBlate System is intended for ablating intracranial soft tissue, including brain structures. There are no known or reported contraindications. The technology is not appropriate for every lesion type and location. It may be difficult to use the technology on certain large or irregularly shaped lesions. Patients must be able to undergo MRI exposure.

Possible adverse events include, but are not limited to, compromised device function, hematoma, embolic events, edema, bleeding, unintended major tissue damage and permanent neurological deficits. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.

Rx Only.