Insightec’s neurosurgery solution, Exablate Neuro, is the first focused ultrasound device approved by the FDA to treat patients with essential tremor. Exablate Neuro is a non-invasive, image-guided personalized thalamotomy, treated through an intact skull that doesn't require any ionizing radiation, incisions or implants.
High intensity focused ultrasound waves precisely target a focal point in the Vim nucleus of the thalamus, the tiny part of the brain that is thought to be responsible for causing tremors. The Exablate Neuro ultrasound transducer consists of 1024 beams that generate enough heat to ablate the targeted tissue during treatment. The result is an immediate and significant reduction of tremor for patients. If you are a patient, please click here for more information: www.essential-tremor.com
The Exablate Neuro is intended for use in the unilateral Thalamotomy treatment of idiopathic Essential Tremor patients with medication-refractory tremor. Patients must be at least age 22. For Exablate Neuro FDA Labeling CLICK HERE.
RISKS - Risks associated with thalamotomy include transient and/or permanent sensory paresthesias, numbness, imbalance, and/or gait disturbance. Risks and adverse events also associated with the Exablate Neuro treatment include sonication-related pain, sonication-related dizziness or nausea or potential for deep vein thrombosis associated with 3-4 hours on the treatment bed.
Essential TremorRead More close
Exablate uses MR guided Focused Ultrasound to perform a “non-invasive” thalamotomy to relieve medication refractory tremor in patients with essential tremor. The effect of MRgFUS is based on tissue destruction within the Vim nucleus of the thalamus which enables a highly accurate and controlled thermal effect.
During planning and treatment for essential tremor, the patient is fully conscious and lying on the treatment bed in an MRI scanner. MRI provides high resolution visualization, patient-specific treatment planning and continuous monitoring of the procedure. Real-time thermal feedback allows the physician to control and adjust the treatment, ensuring that the targeted tissue is completely ablated without impacting adjacent healthy tissue.
Prior to the delivery of high temperatures, the application of lower energy allows for proper anatomic localization, as well as physiologic evaluation of symptom relief and/or any potential side effects. This process allows for adjustments before making a permanent lesion. During treatment, ultrasound energy is delivered across the skull, without an incision or craniotomy, heating the targeted tissue above the protein denaturation threshold at temperatures near 60°C.
Treatment effects are immediate and the several hour treatment is generally well tolerated with mild sedatives.
Parkinson’s DiseaseRead More close
- Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the Exablate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease. For more information CLICK HERE.
Blood Brain Barrier DisruptionRead More close
- This study is designed to assess the safety and feasibility of using the ExAblate, Type 2 to temporarily disrupt the blood brain barrier in non-enhancing suspected glioblastomas. The ExAblate Model 4000 Type-2 is intended for use as a tool to disrupt the BBB. For more information CLICK HERE.
Benign Brain Tumors - PediatricsRead More close
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of Exablate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. For more information CLICK HERE.
Essential Tremor, Parkinson's Disease or Neuropathic PainRead More close
A global post approval study to collect safety and effectiveness data related to Exablate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum. For more information CLICK HERE.
Neuropathic Facial PainRead More close
The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain. For more information CLICK HERE.
EpilepsyRead More close
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a subcortical focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the Exablate transcranial system to produce multiple sonications targeted in the lesion of interest. The investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. For more information CLICK HERE.
Why INSIGHTEC Neurosurgery?
Non-invasive, no penetrating trajectories and no ionizing radiation. Real time MRI for targeting and thermal feedback. Sharp, accurate treatment that allows for lesions as small as 2mm.
No craniotomy, immediate results, minimal risk of infection, bleeding or other surgical complications. Single session treatment, no anesthesia, quick recovery and no implanted hardware.
Short hospitalization. Medical facilities can attract and treat additional patient groups and strengthen their hospital/clinic leadership in innovation and advanced care.
Watch Garth Rees Cosgrove, MD, W. Jeffrey Elias, MD and Ryder P. Gwinn, MD, as they talk about their experience with INSIGHTEC's Exablate Neuro for the treatment of essential tremor including the innovative technology, the MRgFUS technique, side effects and more.
Prof. Takaomi Taira, Director of Stereotactic and Functional Neurosurgery, Dep. Of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan, shares his insights regarding the advantages of Exablate MRgFUS technology in treating movement disorders, and the witnessed change in patients’ quality of life.
Essential TremorApproval Country Year
- USA - FDA APPROVED