Israel’s Insightec announced Wednesday the publication of pivotal data for its noninvasive essential tremor treatment. The device won FDA approval last month on the strength of these data.
The device, dubbed the Exablate Neuro, uses MR-guided ultrasound waves to reach and ablate tissues deep within the brain as a noninvasive alternative to incisions or implants. The treatment, which does not require anesthesia, is guided by MRI in real time.
The randomized, double-blind multicenter study involved 76 patients, with 56 receiving Exablate treatment and 20 undergoing sham treatment, according to a statement. Published in The New England Journal of Medicine, the study met its primary endpoints, indicating a “clinically significant” 47% improvement in composite tremor score three months after treatment. There was no change in the group that underwent a sham treatment.
The patients in the treatment group had a 63% decrease in tremor amplitude, which was preserved at the one-year mark. The patients also rated their quality of life as improving by 51% after one year, according to the statement. In addition to improving essential tremor symptoms, the Exablate Neuro’s noninvasive nature allows patients to return immediately to daily life following the outpatient procedure.
“The robust study findings showed that focused ultrasound safely improved hand tremor in patients with refractory tremor by precisely targeting and ablating deep brain tissue without surgical incisions, thus minimizing risk of infection, bleeding or other complications sometimes seen in surgical operations.” said Dr. William Ondo, Insightec’s Tremor Research Group president.
Insightec partnered with Siemens Healthineers earlier this month to achieve compatibility between the Exablate Neuro and the imaging giant’s MRI systems. The tie-up will make the novel treatment available to more patients and will include patient-specific treatment planning.