ESSENTIAL
TREMOR

Essential tremor, also referred to as familial, idiopathic, or benign tremor, causes uncontrollable shaking that can deeply impact a person’s quality of life. When medications fail to offer relief, surgical intervention may be the next step. Focused ultrasound is a treatment option that provides tremor control without surgical incisions and with minimal complications.1

During the treatment, under MRI guidance, sound waves are precisely focused on the small spot in the brain considered to be responsible for causing tremors. Low energy is first applied, which allows the patient to inform the physician of any sensations they feel or other potential side effects. Then the physician can make individualized adjustments to the target. The energy is gradually increased to create a small therapeutic lesion.

For many patients, the result is immediate improvement of tremor in the treated hand. More than 3,500 patients (and growing everyday) have been treated to date around the world.

1 Pre-Market Approval (PMA) P150038

How it Works and
How it Helps

Discover how Focused Ultrasound can improve hand tremor from Essential Tremor safely and effectively – without a scalpel, hospital stay, or lengthy recovery time.

  • Incisionless Surgery

    Means little to no risk of infection.1

  • Improvement in Hand Tremor

    Stably Maintained at 3 Years.1

  • Single Session Treatment

    With Minimal Hospitalization.

  • Personalized Treatment

    With Sub-millimeter Target Movement.

  • Immediate Tremor Improvement

    Post procedure for most patients.

  • Safe and Effective

    With Minimal Side Effects.1

Clinical Study

Overview

Insightec sponsored a clinical trial of the Exablate® Neuro platform to evaluate focused ultrasound to treat patients with medication-refractory Essential Tremor.

The 3-year data demonstrates a durable reduction in hand tremor and improvement in quality of life in subjects who received focused ultrasound for medication-refractory essential tremor.

Efficacy results

3 year follow up pivotal study of focused ultrasound for essential tremor¹
(See chart)
Percentages represent tremor improvement over baseline.
1 Pre-Market Approval (PMA) P150038

Safety results

Insightec-sponsored clinical studies have shown that the most common adverse events experienced after treatment included: imbalance/gait disturbance (26%), numbness/tingling (33%), and headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.
Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9%), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.

The number in parenthesis is the percentage of active subjects experiencing these adverse events.

For additional safety information, please refer to Pre-Market Approval (PMA) P150038

Safety Information

Important Safety Information

You should have a detailed conversation with your physician regarding complications, also known as adverse events, that you may experience.

Insightec-sponsored clinical studies have shown that the most common adverse events experienced after treatment included: 1) imbalance/gait disturbance (26%), 2) numbness/tingling (33%), and 3) headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.

Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9%), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.

The number in parenthesis is the percentage of active subjects experiencing these adverse events.

For details of the clinical study methods and results, download Clinical Study Results. For additional safety information, please refer to Pre-Market Approval (PMA) P150038

Regulatory Approval

Click here to view the regulatory approvals of Insightec products by country.

Patient
Advocacy

Insightec does not review or endorse any of the organizations listed below and cannot guarantee that the content is accurate or complete. This information is not intended to be a substitute for professional medical advice. Always discuss treatment options with your physician or other qualified health provider.

  • FOCUSED ULTRASOUND FOUNDATION (FUSF)

    FUSF was created to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ultrasound.

    Learn More
  • INTERNATIONAL ESSENTIAL TREMOR FOUNDATION (IETF)

    “Your voice for Essential Tremor”

    IETF is a non-profit organization that provides hope to the essential tremor (ET) community worldwide through awareness, education, support, and research.

    Learn More
  • HOPENET

    HopeNET is a non-profit organization whose purpose is to advocate for, educate, and support those with Essential Tremor.

    Learn More

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