SYSTEM OVERVIEW MINIMALLY INVASIVE ROBOTIC LASER THERMOTHERAPY

Transcription

1 SYSTEM OVERVIEW MINIMALLY INVASIVE ROBOTIC LASER THERMOTHERAPY

2 Software NeuroBlate Fusion Software is the exclusive software intelligence behind the NeuroBlate System. NeuroBlate Fusion allows neurosurgeons to plan, deliver, and monitor MRI-guided robotic laster thermotherapy. TRUTEMP TECHNOLOGY Proton resonance phase drift, which is inherent with all MRI scanners and can account for a several degree temperature variance over short time intervals, is mapped, corrected, and holds baseline temperature. The NeuroBlate System detects patient motion and significant RF noise events, and will automatically shut off the laser when appropriate for added safety. NeuroBlate removes pixels which exhibit unstable MRI signal and can cause inaccurate thermography. Actual baseline body temperature is used as an input, rather than assuming 37 C. This assures that the ablation temperature is accurate for cell death. ADVANCED IMAGE CO-REGISTRATION TOOLS Precisely Shape Ablation Margins for Assured Surgical Accuracy NeuroBlate Fusion Software accepts image data processed by other imaging software, delivering surgeons needed information to optimize visibility and accuracy of the intended ablation target. Enhanced image fusion tools allow for the import of pre-operatively planned, 3D objects, such as autosegmented ablation target(s), post-processed fmri data and DTI (fibertracking data). These objects can be fused to the treatment day MRI, and create 3D volumes in NeuroBlate Fusion superimposed on the background imaging during ablation. ENHANCED VISUALIZATION OF THE ABLATION TARGET Additionally, NeuroBlate Fusion Software offers the ability to delineate the target ablation area or structures to avoid with interactive, multi-planar volume contouring tools. Monitor the intended ablation area in three orthogonal planes, as well as perpendicular slice planes above and below the center of the ablation zone. This eliminates the uncertainty associated with a blind ablation with no defined ablation zone.

3 NEUROBLATE SYSTEM MULTIPLE SCENARIOS. ONE TECHNOLOGY. The NeuroBlate System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through interstitial irradiation or thermal therapy. Mini-Bolt Access MRI Guided Laser Energy Robotically Controlled Probe Driver FINALLY, PRECISION DELIVERED THROUGH A MINIMALLY INVASIVE SURGICAL OPTION NeuroBlate is the only minimally invasive, robotic, laser thermotherapy that uses MRI-guided surgical ablation technology designed specifically for use in the brain. NeuroBlate provides precise and maximal tumor reduction for patients without the invasiveness of an open neurosurgical procedure. The precise nature of the procedure helps lessen the likelihood of harm to nearby healthy tissue.1,2,3,4

4 THE NEUROBLATE SYSTEM IS USED IN A WIDE RANGE OF LESIONS Symmetrical Asymmetrical Difficult to Access NEUROBLATE SYSTEM: THE MINIMALLY INVASIVE SURGICAL CHOICE Multiple Intra-Operative NeuroBlate Keeps a Patient s Options Open If repeat surgery is determined to be required, NeuroBlate offers a minimally invasive surgical option. At this time, there are no contraindications for NeuroBlate that would limit the number of procedures a patient may undergo. NeuroBlate is Minimally Invasive Generally, minimally invasive procedures are well tolerated, have a short recovery time, and patients typically require 1-2 stitches to close the incision. Post-Operative More than 1,800 NeuroBlate procedures since 2008 have been performed in 59 centers.

5 NEUROBLATE DELIVERS A COMPREHENSIVE SYSTEM WITH OPTIONS AND CONTROL The NeuroBlate System portfolio offers a comprehensive, full solution laser ablation system that includes patient stabilization and transport (AtamA Patient Board), probe trajectory (Mini-Bolt Access - available in 2.2 mm and 3.3 mm inner diameters), therapy planning and analysis (NeuroBlate Fusion Software ), and a versatile set of tools for robotic laser thermotherapy (NeuroBlate Robotic Probe Driver, SideFire and FullFire laser probes). MRI Scanner Laser Probe Robotically Controlled Probe Driver NeuroBlate offers two robotically controlled probe options to deliver laser energy during ablation: Patient Board with Head Fixation Robotic MRI Interface NeuroBlate SideFire Laser Probe provides focused, directional ablation NeuroBlate FullFire Diffusing Tip Laser Probe provides fast, volumetric ablation Directional Fiber (Laser beam exit) Thermo-couple CO 2 Cooling Tube Semi-rigid Probe Shaft Robotically Controlled Probe Driver AtamA Patient Board With head fixation and transport Mini-Bolt Access NeuroBlate Fusion Software

6 Economic Value Hospitals may see a variety of benefits from adding NeuroBlate capability. Multiple studies describe a short hospital stay after the LITT procedure. 5,6 In a single center economic analysis, LITT was found to be less costly or a similar cost to traditional surgical methods. 7 As physicians experience with NeuroBlate increases, the procedure time and MRI time decreases further increasing efficiency in the procedure room. 8 Support and Services Dedicated technical and clinical staff delivering training and case support NeuroBlate peer-to-peer mentoring opportunities Indications The NeuroBlate System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate Laser Delivery Probes. It also provides real-time thermographic analysis of selected MRI images. When interpreted by a trained physician, this System 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 the NeuroBlate System analysis. Risks The NeuroBlate System is a surgical tool used in brain surgery to heat and destroy targeted tissue. There are no known or reported contraindications. Patients must be able to undergo MRI exposure. All brain surgeries carry risk. There are potential benefits and risks, e.g., device malfunction, bleeding, edema and unintended major brain 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 event. For full prescribing information please visit monteris.com. REFERENCES 1. Wilson TA, Karajannis MA, and Harter DH. Glioblastoma multiforme: State of the art and future therapeutics. Surg Neurol Int May 8;5: Mohammadi AM and Schroeder JL. Laser interstitial thermal therapy in treatment of brain tumors the NeuroBlate System. Expert Review of Medical Devices :2, Sloan AE, Ahluwalia MS, Valerio-Pascua J, et al. Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article.j Neurosurg Jun;118(6): Carpentier A, McNichols RJ, Stafford RJ, et al. Laser thermal therapy: real-time MRI-guided and computer- controlled procedures for metastatic brain tumors. Lasers Surg Med Dec;43(10): Mohammadi AM et al The role of laser interstitial thermal therapy in enhancing progression-free survival of difficult-to-access high-grade gliomas: a multicenter study. Cancer Med Aug; 3(4): Jethwa et al Magnetic resonance thermometry-guided-laser-induced thermal therapy for intracranial neopasms; initial experience. Neurosurgery 71, (2012). 7. Leuthardt et al A Single-Center Cost Analysis of Treating Primary and Metastatic Brain Cancers with Either Brain Laser Interstitial Thermal Therapy (LITT) or Craniotomy PharmacoEconomics - Open March Monteris data on file CL Rev A. U.S. Office th Ave. N., Suite C Plymouth, MN Canadian Office Unit 1B-25 Scurfield Blvd. Winnipeg, MB R3Y1G monteris.com Rx Only 2018 Monteris. All Rights Reserved. AA10365 Rev A 3/18