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 10,000 patients (and growing everyday) have been treated to date around the world.

1 Pre-Market Approval (PMA) P150038

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Treatment and Benefits

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

Carol’s Documentary

Carol Klein, a lifelong schoolteacher, came to a point in her life where she decided it was time to take control of her shaking hands. She was not going to let Essential Tremor stop her from enjoying life. View Insightec’s documentary about Carol’s incredible journey.

Testimonials may not be representative of all treatment outcomes.

Watch Here

How Is Essential Tremor treated?

From general information about Focused Ultrasound to what a typical treatment day looks like, we are here to help guide you on your journey to tremor treatment. Below we have answered the most frequently asked questions from our patient and caregiver community.

  • What is Focused Ultrasound?
  • Insurance Coverage
  • Am I a Candidate for Focused Ultrasound?
  • Treatment Options for Essential Tremor
  • During and After Treatment
  • Risks and Side Effects

Clinical Study – Pivotal Trial

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 unilateral 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

Clinical Study – Second Side Trial

Overview

Insightec sponsored a clinical study of the Exablate® Neuro platform to evaluate focused ultrasound to unilaterally treat the contralateral side for patients with medication-refractory Essential Tremor who had already received an Exablate focused ultrasound index procedure at least 9 months prior.

The 6-month data demonstrates a durable reduction in hand tremor and improvement in quality of life in subjects who received a unilateral focused ultrasound for medication-refractory essential tremor on their contralateral side from the index focus ultrasound thalamotomy.

Efficacy results

6-month follow up study of focused ultrasound for Essential Tremor2 (See chart) Percentages represent tremor improvement over baseline.
2 Pre-Market Approval (PMA) P150038 – S022

Safety results

The most common adverse events, or complications, reported by subjects in Insightec-sponsored clinical studies after treatment included: Ataxia (24% of study patients), numbness/tingling (33%), dysarthria (29% of subjects), dysgeusia (14% of patients), imbalance (10% of patients), unsteadiness (10% of patients), gait disturbance (10% of patients), dysphagia (10% of patients), hypogeusia (10% of patients).

98% of these events were classified as mild (85%) or moderate (13%), and 51% of all adverse events resolved on their own within 6 months. Additional infrequent (<5%) events dysmetria, fatigue, weakness, decrease in synchronicity, dizziness, dry mouth, hypoesthesia, intermittent diplopia, sialorrhea, voice change, facial droop, headache, and UTI.

They were no device related adverse events.

Only one related serious event occurred – a urinary tract infection following use of catheter during the procedure.
For additional safety information for Staged Unilateral Treatment of the Contralateral Side, please refer to Pre-Market Approval P150038 Supplement S022. Again, you should discuss in detail the risks, benefits and treatment options with your physician prior to treatment.

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.

SECOND SIDE
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 – S022 (Premarket Approval (PMA) (fda.gov))

Regulatory Approval

FDA Approved

In the unilateral thalamotomy treatment of idiopathic Essential tremor patients with medication-refractory tremor and in the staged (by at least 9 months from the first thalamotomy), unilateral thalamotomy of idiopathic Essential tremor patients with medication-refractory tremor of their contralateral side that was not previously treated in the index unilateral thalamotomy. Patients must be at least age 22. 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.

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

Patient Advocacy
Groups

From working diligently toward medical advances, to providing holistic community support, Advocacy groups like the ones below champion both patients and the healthcare professionals treating them.

  • Focused Ultrasound Foundation (FUSF)

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

    Visit Website
  • International Essential Tremor Foundation (IETF)

    “Your voice for Essential Tremor”
    The International Essential Tremor Foundation. IETF is a non-profit organization that provides hope to the essential tremor (ET) community worldwide through awareness, education, support, and research.

    Visit Website
  • HOPENET

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

    Visit Website

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