Monteris Medical Announces Launch of FDA-Cleared NeuroBlate® SideFire™ Select™ and FullFire™ Select™ Reduced Diameter Laser Mini-Probes For Minimally Invasive Robotic Laser Thermotherapy

Company to unveil new probes and present clinical data at the 83rd American Academy of Neurological Surgeons (AANS) Annual Scientific Meeting

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Monteris Medical

May 01, 2015, 09:59 ET

WASHINGTON, May 1, 2015 /PRNewswire/ -- Monteris Medical today announced the launch of two new reduced diameter mini-probes for its NeuroBlate^® System, a minimally invasive robotic laser thermotherapy tool. The new probes will be highlighted during the 83^rd American Academy of Neurological Surgeons (AANS) Annual Scientific Meeting, taking place from May 2-6 in Washington, D.C. In addition, Monteris Medical announced new clinical data supporting the use of NeuroBlate in neurological surgery procedures will be presented during the conference.

Monteris Medical's new mini-probes have a reduced outer diameter of 2.2 mm. Each of the new FDA-cleared probes offers distinct advantages, depending on a surgeon's particular procedural needs: SideFire™ Select™ is a directional laser for contoured ablation of targets while preserving adjacent healthy tissue, whereas the FullFire™ Select™ is a diffusing laser designed to provide fast, volumetric ablation in a concentric zone of hyperthermia.

NeuroBlate SideFire Select and FullFire Select laser mini-probes can easily be used within a standard MRI bore, and can also be used in conjunction with Monteris Medical's signature Robotic Probe Driver and Mini-Bolt, as well as other skull fixation devices.

"The new 2.2 mm probes retain outstanding target localization and laser ablation characteristics while having less impact on intervening tissue along the trajectory," said Adrian W. Laxton, M.D., assistant professor, Department of Neurosurgery, Wake Forest Baptist Medical Center.

The NeuroBlate System employs a pulsed surgical laser to deliver targeted energy to ablate soft tissue in neurosurgery procedures. With the option of selecting 3.3 mm or 2.2 mm probes, Monteris offers surgeons the full spectrum of probe choice and added versatility. Each of the probes employs proprietary hyperthermia modulation and a unique sapphire capsule with high laser transparency and robust thermal properties. The probes can also be controlled remotely through Monteris Medical's Robotic Probe Driver.

"The smaller diameter probes confer several advantages during neurosurgical procedures," said Alireza Mohammadi, M.D., Assistant Professor of Neurosurgery at a prominent Ohio academic hospital. "The new laser probes have exactly the same efficacy of their larger counterparts, but have a lower profile design and are optimally suited for operating on lesions located in the critical areas of the brain, allowing us to perform surgery on lesions previously thought to be inoperable."

"We were able to take all of the advanced features and capabilities of our 3.3 mm probe and miniaturize them all, without sacrificing any performance versus the original probe," said Richard Tyc, Vice President, Technology and Advanced Development at Monteris Medical. "This reduced diameter option for surgeons who wish to work with smaller instrumentation underscores our goal and commitment to listen carefully to customers and repeatedly demonstrate our ability to bring new capabilities to our NeuroBlate platform."

The NeuroBlate System is considered to be minimally invasive surgery. With the NeuroBlate System, a surgeon makes a small hole in the skull, approximately as wide as a pencil. A small probe is then used to deliver laser light energy to heat and destroy the tumor. The NeuroBlate System combines magnetic resonance imaging (MRI) and software-based visualization to allow surgeons to remotely ablate tumors in many locations in the brain, at the surface or deep inside, through a computer module. An MRI compatible robotic probe driver helps the surgeon precisely guide the laser probe to the tumor and apply heat to it in controlled amounts, until the targeted tissue is destroyed.

With its minimally invasive approach, the NeuroBlate System has shown results analogous to open surgery.^[i]Patients undergoing procedures with the NeuroBlate System may experience less pain compared with those undergoing open surgical procedures and reduced hospital length of stay over open surgical procedures.^{[i],[ii],[iii]}

Monteris Medical also announced new clinical data during AANS highlighting real world applications of the NeuroBlate System in surgical case studies and supporting its clinical efficacy:

Title: To Biopsy or To NeuroBlate^®? Early Outcomes in Glioblastoma*
Date & Time: Tuesday, May 5 (5:21- 5:30 p.m.)
Lead Author: Manmeet Ahluwalia, M.D., Section Head, Neuro-Oncology Outcomes, Cleveland Clinic Brain Tumor and Neuro-Oncology Department

Title: Laser Neuro-Ablation for Metastases Failing Radiosurgery – a Multicentered Retrospective Study*
Date & Time: Wednesday, May 6 (4:50 - 4:59 p.m.)
Lead Author: Veronica L.S. Chiang M.D., Associate Professor of Neurosurgery and of Therapeutic Radiology, Yale New Haven Hospital

Title: A Novel Minimally Invasive Approach for Large Intracranial Tumors: Combination of MRI-Guided Laser Ablation and Endoscopic Assisted Internal Debulking of Tumor*
Date & Time: Poster Session
Lead Author: Alireza Mohammadi, M.D., Assistant Professor of Neurosurgery at Cleveland Clinic

*About the NeuroBlate System^®

The NeuroBlate System is FDA-cleared to ablate, necrotize or coagulate soft tissue encountered in the discipline of neurosurgery through the application of laser thermotherapy. NeuroBlate is a tool (as opposed to a "treatment") and is not intended to treat any specific disease. Physicians should use their clinical judgment and experience when deciding whether to use NeuroBlate.

Since it received clearance from the U.S. Food and Drug Administration (FDA) in April 2013, the NeuroBlate System has been adopted for use in more than 22 leading institutions across the country including Cleveland Clinic, UC San Diego Health System, Barnes Jewish Hospital, Washington University and Yale New Haven Hospital. Monteris Medical supports the installation of new systems with comprehensive hands-on training and ongoing technical support.

Full prescribing information for the NeuroBlate System is available at www.monteris.com.

About Monteris^®

Monteris Medical is a privately held company developing devices for minimally-invasive, MR-guided neurosurgery. Monteris markets the NeuroBlate^® System for controlled, volumetric ablation of brain lesions. Monteris also offers the various Stereotactic anchoring devices for image-guided trajectory alignment, and the AtamA™ Stabilization System for MR based procedures requiring versatile head fixation.

For more information on Monteris Medical please visit www.monteris.com.

[i] Hawasli AH, Bagade S, Shimony JS, et al. Magnetic resonance imaging-guided focused laser interstitial thermal therapy for intracranial lesions: single-institution series. Neurosurgery. 2013 Dec; 73(6):1007-17.

[ii] 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. 2013 Jun; 118(6):1202-19.

[iii] Mohammadi, AM and Schroeder, JL. Laser interstitial thermal therapy in treatment of brain tumors – the NeuroBlate System. Expert Review of Medical Devices 2014 11:2, 109-119.

SOURCE Monteris Medical