The NeuroBlate System (also known as laser interstitial thermal therapy, or LITT) applies focused laser energy to ablate brain tumors from the inside, minimizing the effect on surrounding healthy tissue. Recently, data from two separate studies, highlighting the clinical utility of LITT, were presented at the American Association of Neurological Surgeons (AANS) 84th Annual Scientific Meeting.
To gain further insight on NeuroBlate’s design and potential usefulness in a clinical environment, MDT spoke to Richard Tyc, VP of technology and advanced development for Monteris Medical. Here’s what he had to say:
MDT: Could you provide a brief history of how NeuroBlate was conceived and developed?
Tyc: My long-time colleague Dr. Mark Torchia, Associate Professor of Surgery in the College of Medicine, Faculty of Health Sciences, University of Manitoba came up with the original concept for a small laser delivery probe to be used stereotactically to target and destroy intracranial lesions using heat in an effort to help the thousands of patients who are told each year that they have an inoperable brain tumor.
The idea was to create a device that a surgeon could use to locate a brain tumor using real-time MRI, and then precisely destroy the tumor with controlled doses of lethal heat produced by a laser under real time image guidance. With a small core group of engineers, we started development of AutoLITT in 1999, the technology that gave rise to NeuroBlate, as a minimally invasive alternative to open brain surgery that could allow surgeons to effectively target brain lesions while minimizing patients’ pain and recovery time. In 2003 we founded Monteris Medical, where we focused on engineering a smaller device probe capable of focal energy delivery guided using real time MR imaging.
Over the years Monteris has continually improved its technology to better serve surgeon and patient needs. For example, the surgery sessions have become shorter, and the laser probes have become smaller and with increased energy delivery.
In 2009, the system was cleared by the FDA and in 2010 was first used in humans at facilities including Cleveland clinic, Case Western and Barnes-Jewish Hospital.
MDT: What were some of the challenges of developing the NeuroBlate System and the engineering strategies used to overcome these challenges?
Tyc: While in the early stages of development, we were told by many that the concept was impossible or unrealistic. One significant challenge was ensuring that the device reliably worked in tandem with MRI imaging. In one way, the technology had to catch up to the original design Dr. Torchia proposed. MRI, for one, was a diagnostic imaging tool but its use for thermal imaging was not perfected yet. We started development first on a low field MRI in 2000-02 but quickly found it would not be sufficient for our needs and turned to the high field MRIs used today. A significant challenge was making a device work in an MRI which is fundamentally problematic – it is based on a very strong magnet and uses significant RF energy to produce images – two things that make device design capable of operating in this environment a complex engineering problem.
Although LITT (Laser Interstitial Thermal Therapy) methods were already in use for neurological conditions at the time we developed NeuroBlate, the available options were somewhat limited and did not give surgeons adequate control to precisely target specific brain lesions. We addressed this by inventing the “side-fire” cooled probe which fires the laser at approximately a 90 degree angle. This demanded development of a probe design that also integrated a novel cooling mechanism to augment the focal laser energy delivery of the side fire probe to ensure thermal progression of heat remain focal in a user defined direction.
MDT: How does NeuroBlate impact the surgeon and patient experience?
Tyc: With traditional brain operations, MRI is used after the surgery to determine if the lesion had been removed. With NeuroBlate, MRI is used throughout the procedure, allowing for real-time surgical decision-making. Furthermore, the delivery of the laser probe is in a minimally invasive route to the target via a small 4.5mm twist drill hole in the skull. This provides a significant advantage to the patient compared to open craniotomy and recovery time can be much shorter.
The obvious benefit for the patient is that NeuroBlate can reach deep-seated difficult to reach areas in the brain and may therefore be an option for some patients who are told their condition is inoperable through traditional open surgery. In addition, NeuroBlate – because it is considered a minimally invasive procedure – may result in an improved patient experience. There is significantly less post-op pain and usually a shorter recovery time, and patients can generally return home and to work more quickly. Risks with procedures such as laser ablation are low and similar to those posed by other surgical alternatives. In addition, laser ablation has comparatively fewer side effects, including post-op pain, risk of infection, and cerebrospinal fluid leakage, likely because of the smaller hole required for the procedure.
MDT: What are some of the advantages of laser thermotherapy?
Tyc: New technologies and treatment modalities are helping physicians custom-tailor treatment in order to achieve the best care for every patient. Laser therapy gives physicians an additional tool, which can sometimes be used as an adjunct to traditional therapy. Compared to other thermal therapies like Cryoablation or RF ablation, laser energy delivery into the MRI suite is immune to the MRI environment being passed via fiber optics. Image guidance is critical in the brain where the surgeon demands precision and detailed knowledge of the ablation zone. In addition to integrating the benefits of real-time MRI, laser thermotherapy enables a minimally invasive approach to treat specific areas and contours, and gives surgeons easier access to tumors that are difficult to reach with standard surgery.
MDT: What future NeuroBlate developments does Monteris anticipate in the coming months/years?
Tyc: Demand for NeuroBlate has increased in recent years, a trend we expect to continue. Though laser ablation is still a relatively newer option for the treatment of brain tumors and various other neurological soft tissue lesions, its clinical utility has been established in a growing body of evidence.
We continue to install the NeuroBlate System at leading treatment centers in the U.S. and Canada, and hope to make it an option for as many patients as possible. Monteris will of course continue its commitments to research, and more opportunities will continue to emerge as physicians become more comfortable with LITT.
One specific area with ongoing developments related to laser ablation is medically refractive epilepsy, a serious condition with significant unmet needs. While many patients are eligible for surgical resection to treat their condition, physicians and patients are often hesitant to perform an invasive procedure with potentially serious side effects. Monteris has an FDA-approved IDE study underway to evaluate the potential of LITT in order to better understand if this type of treatment is a safe and effective alternative to open surgery.