Technology | Focused Ultrasound Therapy | December 21, 2018

Focused ultrasound device indicated for unilateral thalamotomy with medication-refractory tremor patients

FDA Approves Exablate Neuro for Tremor-Dominant Parkinson's Treatment

December 21, 2018 — Insightec announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication of Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson's disease (PD).

The Exablate Neuro is a focused ultrasound device for performing incisionless thalamotomy guided by magnetic resonance imaging (MRI). This expansion adds medication-refractory tremor from PD to the current Exablate Neuro indication for incisionless, focused ultrasound thalamotomy for medication-refractory essential tremor.

"This is another validation of a great technology," said Jeff Elias, M.D., of the University of Virginia School of Medicine. "Patients are attracted to the less invasive aspects of focused ultrasound. Now Parkinson's patients, for whom tremor is their primary disability, have more treatment options than conventional cranial surgery. While focused ultrasound is not curative for Parkinson's disease, it can provide significant quality of life benefits. Research continues for the other symptoms of Parkinson's," he concluded.

Tremor, rigidity, slowness of movement and postural instability are the cardinal features of Parkinson's disease (PD). In an estimated 10 - 20 percent of PD patients, the primary symptom is tremor. These patients initially have tremor and as the disease progresses, they may experience an onset of relatively mild bradykinesia and rigidity. Upon further disease progression, tremor remains the symptom with the most severe impact on daily activities.

During the focused ultrasound treatment, sound energy passes safely through a patient's skull, with no surgical incisions, to heat and precisely ablate the target in the thalamus. The treatment allows the neurosurgeon to create a personalized treatment plan and to evaluate feedback of the patient's symptom relief or potential side effects in real-time. Patients must be at least 30 years of age.

This approval was based on data from a study led at the University of Virginia School of Medicine and was also conducted at Swedish Neuroscience Institute in Seattle.

For more information: www.insightec.com


Related Content

News | Artificial Intelligence

November 29, 2022 — Quantivly is highlighting new advances in its artificial intelligence (AI)-driven software for ...

Time November 29, 2022
arrow
News | Magnetic Resonance Imaging (MRI)

November 29, 2022 — Two studies comparing injections commonly used to relieve the pain of knee osteoarthritis found that ...

Time November 29, 2022
arrow
News | Pediatric Imaging

November 28, 2022 — Using MRI data from the largest long-term study of brain development and child health in the United ...

Time November 28, 2022
arrow
News | RSNA

November 27, 2022— Royal Philips, a global leader in health technology, today announces its portfolio of smart ...

Time November 27, 2022
arrow
News | Enterprise Imaging

November 26, 2022 — FUJIFILM Healthcare Americas Corporation, a leading provider of enterprise imaging and informatics ...

Time November 26, 2022
arrow
News | Magnetic Resonance Imaging (MRI)

November 23, 2022 — For the first time, a new study has identified enlarged perivascular spaces in the brains of ...

Time November 23, 2022
arrow
News | Pediatric Imaging

November 23, 2022 — Researchers analyzing the data from MRI exams on nearly 8,000 children have identified biomarkers of ...

Time November 23, 2022
arrow
News | Pediatric Imaging

November 22, 2022 — A new MRI study revealed that consumption of alcohol even in low to moderate amounts during ...

Time November 22, 2022
arrow
News | Magnetic Resonance Imaging (MRI)

November 21, 2022 — Using a special type of MRI, researchers have uncovered brain changes in patients up to six months ...

Time November 21, 2022
arrow
News | Magnetic Resonance Imaging (MRI)

November 17, 2022 — According to an accepted manuscript published in ARRS’ American Journal of Roentgenology (AJR) ...

Time November 17, 2022
arrow
Subscribe Now