“Exablate Neuro” Ultrasound Tech Wins FDA Nod as Essential Tremor Treatment

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“Exablate Neuro” Ultrasound Tech Wins FDA Nod as Essential Tremor Treatment

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“Exablate Neuro” Ultrasound Tech Wins FDA Nod as Essential Tremor Treatment

InSightec has received “premarket approval” which limits the use of this device to treatment of idiopathic Essential Tremor.

“FDA’s approval order requires InSightec to conduct follow up studies evaluating patients from the clinical trial each year through five years following treatment in order to gather long-term information about the treatment’s safety and efficacy.”

“Focused ultrasound’s main advantage is that the treatment is noninvasive, said Vibhor Krishna, MD, a neurosurgeon at The Ohio State University Wexner Medical Center, one of the clinical trial sites. Patients may feel headaches, dizziness, and numbness in parts of the body with each 10-15 second pulse of ultrasound. Krishna said that surgeons do “mini-treatments” first, increasing the temperature slightly and testing to see if the ultrasound is targeting the right part of the brain.

…But Krishna added that focused ultrasound offers an alternative to deep brain stimulation, not a replacement. Some patients have skulls too thick for ultrasound. In other cases, patients who have balance, coordination, or swallowing problems face the risk of their symptoms becoming worse with ultrasound treatment. That’s because the thalamus is also involved in coordination, speech, and walking. If someone has problems with these functions prior to surgery, or if the thalamus on both sides of the brain is affected, ablating tissue could worsen symptoms—changes that are permanent,  Krishna said. In contrast, deep brain stimulation’s advantage is the ability to adjust the electric signal as symptoms change.”

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