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07-12-2016, 11:28 PM
Exablate Neuro MRI-Guided Focused Ultrasound for Essential Tremor **w Available in U.S.
http://www.medgadget.com/wp-content/uploads/2016/07/Exablate.jpg
INSIGHTEC, a company out of Israel, has an**unced receiving FDA approval to offer its*Exablate Neuro MRI-guided focused ultrasound system as a treatment option for essential tremor in patients **t responding to meds. The tech**logy delivers sound waves powerful and focused e**ugh to **n-invasively ablate*bits of*brain tissue responsible for generating improper*neural signals. Treatment is fairly short, and results are often confirmed within seconds, before the patient is even pulled out of the machine. Anesthesia is **t necessary during the procedure, and the patient gets to go home right after.
Some details of the study that led to the FDA’s decision, according to INSIGHTEC:
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of **n-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had ** improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
Here’s a year old video from University of Virginia Health System about using focused ultrasound to treat essential tremor:
Flashbacks:*Exablate Neuro MRI-Guided Focused Ultrasound: Cleared in EU for Neurological Disorders… (http://www.medgadget.com/2012/12/exablate-neuro-mri-guided-focused-ultrasound-cleared-in-eu-for-neurological-disorders.html);*ExAblate MR Guided Focused Ultrasound Approved in U.S. for Pain Treatment in Cancer Patients with Bone Metastases… (http://www.medgadget.com/2012/10/exablate-mr-guided-focused-ultrasound-approved-in-u-s-for-pain-treatment-in-cancer-patients-with-bone-metastases.html);*MRI Guided Focused Ultrasound for **ninvasive Treatment of Prostate Cancer… (http://www.medgadget.com/2010/08/mri_guided_focused_ultrasound_for_**ninvasive_trea tment_of_prostate_cancer.html)
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http://www.medgadget.com/wp-content/uploads/2016/07/Exablate.jpg
INSIGHTEC, a company out of Israel, has an**unced receiving FDA approval to offer its*Exablate Neuro MRI-guided focused ultrasound system as a treatment option for essential tremor in patients **t responding to meds. The tech**logy delivers sound waves powerful and focused e**ugh to **n-invasively ablate*bits of*brain tissue responsible for generating improper*neural signals. Treatment is fairly short, and results are often confirmed within seconds, before the patient is even pulled out of the machine. Anesthesia is **t necessary during the procedure, and the patient gets to go home right after.
Some details of the study that led to the FDA’s decision, according to INSIGHTEC:
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of **n-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had ** improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
Here’s a year old video from University of Virginia Health System about using focused ultrasound to treat essential tremor:
Flashbacks:*Exablate Neuro MRI-Guided Focused Ultrasound: Cleared in EU for Neurological Disorders… (http://www.medgadget.com/2012/12/exablate-neuro-mri-guided-focused-ultrasound-cleared-in-eu-for-neurological-disorders.html);*ExAblate MR Guided Focused Ultrasound Approved in U.S. for Pain Treatment in Cancer Patients with Bone Metastases… (http://www.medgadget.com/2012/10/exablate-mr-guided-focused-ultrasound-approved-in-u-s-for-pain-treatment-in-cancer-patients-with-bone-metastases.html);*MRI Guided Focused Ultrasound for **ninvasive Treatment of Prostate Cancer… (http://www.medgadget.com/2010/08/mri_guided_focused_ultrasound_for_**ninvasive_trea tment_of_prostate_cancer.html)
This post Exablate Neuro MRI-Guided Focused Ultrasound for Essential Tremor **w Available in U.S. (http://www.medgadget.com/2016/07/exablate-neuro-mri-guided-focused-ultrasound-essential-tremor-**w-available-u-s.html) appeared first on Medgadget (http://www.medgadget.com).
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