Market Approval for Treatment of Tremors in ET and Parkinson’s in Brazil

The Brazilian Health Regulatory Agency, ANVISA, has granted market approval to Insightec for their focused ultrasound, Exablate 4000. This MR-guided ultrasound is used for the treatment of tremors that define essential tremor (ET) and Parkinson’s disease. Now that they have received approval, Insightec will partner with Strattner to make the treatment available to the people of Brazil.

Exablate 4000 in Brazil

Insightec and Strattner will work together to bring Exablate 4000 to Brazilian patients. As Strattner works in the field of minimally invasive and robotic surgeries, specifically distributing the necessary equipment for these procedures to medical centers, they are the perfect partner for Insightec.

This MR-guided focused ultrasound uses no incisions but is still able to ablate tissue that is deep within the brain. It was created to treat those with ET or Parkinson’s and is being further studied for those with neuropathic pain.

Already, some of the top medical centers throughout the world utilize Exablate 4000. They have seen nearly immediate relief paired with minimal side effects. In addition to these benefits, treatment can be performed in a single session.

It is now time to bring this technology to Brazil, where millions live with tremors. Hopefully, Strattner and Insightec are able to do so and improve the lives of patients.

About Essential Tremor

This progressive nervous system disorder is characterized by involuntary shaking. While it is not typically dangerous, it can impede patient quality of life. These tremors often begin on one side of the body before progressing to include the entire body. During an episode, symptoms often begin in the hands before spreading. While these episodes are random, there are risk factors that can worsen them. These include extreme temperatures, movement, fatigue, stress, and caffeine.

Symptoms are the result of a genetic mutation for about half of all cases, and medical professionals are unsure as to what causes the other half. For the inherited version, it is passed down in an autosomal dominant pattern. Regardless of cause, treatment is the same. For some, it is not even necessary, as their effects are mild. For others, doctors prescribe tranquilizers, beta blockers, Botox injections, or anti-seizure medications. They may also recommend physical and occupational therapy. For those who experience severe symptoms, deep brain stimulation or a focused ultrasound thalamotomy may be an option.

About Parkinson’s Disease

Parkinson’s disease is a progressive disorder that affects the central nervous system (CNS). It is characterized by its effect on movement through five different stages. As the disease progresses, severity increases.

  • Stage one is characterized by subtle tremors on one side of the body.
  • In stage two symptoms are more noticeable, with tremors and rigidity on both sides of the body.
  • Stage three brings loss of balance and slowed movement.
  • Stage four makes it impossible for one to live independently.
  • Stage five is the most severe, as patients cannot stand or walk. Hallucinations and delusions are common symptoms of this stage.

Parkinson’s disease occurs due to the death of motor neurons, some of which produce dopamine. Dopamine is important in the transmittance of messages to the muscles from the brain, so the loss of dopamine results in the loss of motor functions. Abnormal brain activity occurs when these neurons are lost. Doctors do not know why these motor neurons die, but they do suspect a few factors that play a role, such as genetics, environmental factors like toxins, and Lewy bodies.

Find the source article here.

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