Insightec’s Exablate Neuro system, used as a noninvasive treatment of essential tremor, has been approved by the FDA. Rather than making incisions or implants in the brain, Exablate Neuro uses focused ultrasound waves to target and ablate tissue. Magnetic resonance imaging (MRI) is used as guidance throughout the treatment and offers real-time treatment monitoring.
Insightec noted that patients are able to go right back to their day-to-day lives after the outpatient treatment. Patients experience immediate tremor relief and have minimal risk of infection, bleeding or other complications. The treatment does not require anesthesia.
The FDA based its approval on data from a randomized, double-blind, multicenter clinical study. The study--which enrolled 76 patients--evaluated the safety and efficacy of noninvasive thalamotomy with MRgFUS.
Of the 76 patients, a random selection of 56 were given the Exablate treatment while the remaining 20 received a sham procedure (the same procedure without any ultrasound energy). Those who were given the Exablate treatment showed a near 50% improvement in tremors and motor function three months after the treatment. A year after treatment, Exablate patients still showed a 40% improvement in tremors compared with their original baseline.
Those who received the sham treatment were later permitted to undergo Exablate treatment.
"The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing," said W. Jeffrey Elias, the director of stereotactic and functional neurosurgery at the University of Virginia, in a statement. Elias was the principal investigator on the study.
"I am confident that we have arrived at a tipping point for non-invasive medical treatment,” said Maurice Ferré, CEO and chairman of the board at Insightec. “Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body.”
Exablate Neuro has already been approved by Health Canada for essential tremor.
- here is the press release
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