Focused Ultrasound Now FDA Approved to Treat Essential Tremor Patients’ Second Side


Key Points

  • Patients with essential tremor can now have their second side treated with focused ultrasound.
  • ET commonly affects both sides of the body, and to date, focused ultrasound was only approved for unilateral treatments.
  • The ruling was based on data that showed a highly significant reduction in tremor following treatment of the second side.

The US Food and Drug Administration (FDA) will now allow appropriate patients with essential tremor (ET) to have focused ultrasound treatment on the second side of their brain.

ET is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million individuals in the US. It is often viewed as a relatively benign disease, but it can have substantial effects on quality of life for many patients. The disorder commonly affects both sides of the body.

In July 2016, the FDA cleared Insightec’s Exablate Neuro focused ultrasound device to treat one side of the brain, generally the side that alleviates tremors on the patient’s dominant side.

Now, patients who have undergone focused ultrasound treatment on one side can have the second side treated at least nine months after the initial procedure. This “second side” procedure may also be referred to as bilateral treatment.

According to an Insightec press release, the ruling was based on data from a study that showed a highly significant reduction in tremor following treatment of the second side. Learn more about that trial >

Focused ultrasound is also being investigated in clinical trials for the bilateral treatment of Parkinson’s disease.

Read the Insightec Press Release >

Meet Tom

Tom was thrilled when he was invited to participate in a clinical trial to receive a second focused ultrasound procedure to address the tremor in his non-dominant hand. Tom and his brother Phil talk about their experience with focused ultrasound and their hope that the technology can become more readily available for others, including many in their extended family who have also been affected by ET.