Health Canada approves Insightec’s Exablate Neuro system for the treatment of essential tremor


exablate-neuro-platform-approved-by-korean-ministry-of-food-and-drug-safety-320x202INSIGHTEC has announced that Health Canada has approved its Exablate Neuro system for the treatment of essential tremor.

INSIGHTEC’s Exablate Neuro platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to lesion the targeted tissue deep in the brain, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcomes.

Data presented to Health Canada demonstrated a clinically meaningful effect of the treatment making the disease more manageable and less debilitating. Due to its non-invasive nature, the procedure is performed while the patient is fully conscious, with no incisions and no anaesthesia. The results are immediate and the patient is able to return to normal activities within days.

“Thanks to this favourable decision, Canadian essential tremor patients suffering significant disability now have access to a new incision-less treatment option that offers immediate results,” says Richard Schallhorn, INSIGHTEC’s vice president of Neurosurgery. “Previous treatment options for patients who do not respond to drugs have either involved ionizing radiation or have been significantly more invasive involving implanted hardware,” he adds.

“This is a major breakthrough in the treatment of essential tremor,” says Andres Lozano, Dan Family Professor and chairman of Neurosurgery at Toronto Western Hospital, University of Toronto, Canada. “We are excited to offer our patients a new, minimally-invasive therapy to control their tremors and effectively treat their debilitating symptoms. The patients we have treated so far with this technique have had significant relief of their tremor and a very quick recovery with minimal adverse events”, he says.

INSIGHTEC’s Exablate Neuro system was CE marked for the treatment of essential tremor, tremor dominant Parkinson’s disease and neuropathic pain in 2012 and is currently under FDA review for the treatment of essential tremor. The Health Canada approval includes Exablate Neuro 3T, 1.5T systems and the 1.5 head coil.