This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED)
and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Exablate Model 4000 Type 1.0 and 1.1 Systems
PMA Applicant: InSightec, Inc.
Address: 4851 LBJ Freeway, Suite 400, Dallas, Texas 75244
Approval Date: December 16, 2018
Approval Letter: Link to Approval Order
What is it?
The Exablate Model 4000 Type-1.0 and 1.1 System is a transcranial, magnetic resonance image-guided focused ultrasound (“MRgFUS”) system that treats tremors non-invasively by applying thermal ablation (energy used to remove or destroy tissue) to specific areas of brain tissue. It is used to treat essential tremor in patients whose tremors cannot be controlled using medication.
The current supplement allows the Exablate system to be used for the single-side destruction of a tiny part of the thalamus (unilateral thalamotomy [ventralis intermedius]) to treat Tremor Dominant Parkinson’s Disease (TDPD) with tremors that do not respond to medication. Patients must be at least age 30 years.
How does it work?
Patients undergoing treatment with the Magnetic Resonance Image (MRI)-guided Exablate Neuro device lie in an MRI scanner that takes images to help a doctor identify the targeted area in the brain’s thalamus for treatment. The ultrasound treatment is applied in incremental increases in energy called sonications. After each sonication, patients are asked what they feel and the doctor evaluates the reduction in tremor until a satisfactory result is achieved. Patients are awake and responsive during the entire treatment.
When is it used?
The Exablate system is now approved for the single-side destruction of a tiny part of the thalamus (unilateral thalamotomy [ventralis intermedius]) to treat Tremor Dominant Parkinson’s Disease (TDPD) with tremors that do not respond to medication. Patients must be at least age 30 years.
The Exablate Neuro is also approved for use in patients with essential tremor whose tremors cannot be treated using medication. Patients must be at least 22 years old. The designated area in the brain responsible for the movement disorder symptoms (ventralis intermedius) must be identified and accessible for targeted thermal ablation by the Exablate device.
What will it accomplish?
The Exablate system is intended to accurately guide the focus of the ultrasound energy to the target region to help reduce tremors in patients with essential tremor and Tremor Dominant Parkinson’s Disease that do not respond to medication.
The new TDPD indication was studied in a randomized clinical trial with 20 patients in the treated group, and 7 patients in the control group. The study population consisted of patients at least 30 years of age with Parkinson’s Disease who failed tremor medications (medication refractory).
This Exablate test group showed an improvement at three months of 51.9% while the control patients showed an improvement of only 12.7%. At 12 months, the treated patients showed an improvement of 45.9% over baseline. Six of the seven control subjects were moved to the treatment group at 3 months, so there is no 12-month outcome data for the control control group.
The safety assessment was based on the number of adverse events occurring during the study at 12 months. Ninety five percent of reported adverse events were determined to be mild or moderate over the 12 month period. There were no unanticipated adverse device events reported for the treated and control group during this study.
When should it not be used?
The Exablate should NOT be used in:
- patients who cannot have MR imaging because they have a non-MRI compatible implanted metallic device such as a cardiac pacemakers, allergies to MR contrast agent, or other reasons for MR ineligibility.
- women who are pregnant
- patients with advanced kidney disease or on dialysis
- patients with unstable heart conditions or severe hypertension
- patients exhibiting any behavior consistent with ethanol or substance abuse
- patients with a history of abnormal bleeding, hemorrhage, and/or blood clotting disorders (coagulopathy), or those currently taking anticoagulant drugs or drugs known to increase the risk of hemorrhage
- patients with a history of cerebrovascular disease (strokes) or brain tumors
- patients who are not able to tolerate the prolonged stationary position during treatment
- patients who have an Overall Skull Density Ratio of 0.45 (± 0.05) or less as calculated from the screening Computed Tomography (CT).