Medical Devices

ExAblate 4000 Type 1.0 System – P150038

Image of ExAblate 4000 Type 1.0 System

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 System (ExAblate Neuro)
PMA Applicant: InSightec, Inc.
Address: 4851 LBJ Freeway, Suite 400, Dallas, TX 75244
Approval Date: July 11, 2016
Approval Letter:

What is it? The ExAblate Model 4000 Type 1.0 System (ExAblate Neuro) is a magnetic resonance image-guided focused ultrasound (MRgFUS) system that treats tremors non-invasively by destroying tiny areas of brain tissue. It is used to treat essential tremor in patients whose tremors cannot be controlled using medication.

How does it work? The ExAblate Neuro combines two technologies: magnetic resonance imaging (MRI) to identify the area in the brain’s thalamus that is thought to be responsible for the tremor and a focused ultrasound beam to heat and destroy the tissue.

The ultrasound treatment is applied in incremental increases in energy called sonications. After each sonication, the patient and doctor evaluate 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 Neuro is intended 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 device may reduce a patient’s essential tremor and increase motor function.

Data supporting the approval of this device system included a randomized double-blind control trial involving 76 patients with essential tremor that had not responded to medication therapy. Fifty-six (56) of the patients received the ExAblate Neuro treatment and twenty (20) received a sham treatment. Patients in the sham group were able to cross over into the treatment group after months. After three months, the ExAblate group demonstrated nearly a 50 percent improvement in their tremors and motor function (composite tremor/motor function score) compared to their baseline score before treatment, while the sham group had virtually no improvement and even a slight worsening. At 12 months, the treatment group retained a 40 percent improvement compared to baseline.

When should it not be used? The ExAblate Neuro treatment is contraindicated for use in

  • patients with standard contraindications for MRI including non-MRI compatible implanted metal devices (such as cardiac pacemakers), allergies to MRI contrast agent(s), 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 a screening Computed Tomography (CT).

Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.



Page Last Updated: 07/25/2016
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