HEALTH CANADA APPROVES INSIGHTEC’S EXABLATE NEURO SYSTEM FOR THE TREATMENT OF ESSENTIAL TREMOR
INSIGHTEC, the leader in MR guided Focused Ultrasound (MRgFUS) therapy announces today 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.
Essential tremor is the most common movement disorder, affecting millions of people worldwide. It is a progressive and debilitating neurological condition that causes a rhythmic trembling of the hands, head, voice, legs or trunk. Exablate Neuro was investigated as a treatment alternative for these patients.
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 anesthesia. The results are immediate and the patient is able to return to normal activities within days.
“Thanks to this favorable decision, Canadian essential tremor patients suffering significant disability now have access to a new incision-less treatment option that offers immediate results,” said Richard Schallhorn, INSIGHTEC’s VP 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 added.
“This is a major breakthrough in the treatment of Essential Tremor,” said Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto. “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 emphasized.
Maurice R. Ferré, MD, CEO and Chairman of INSIGHTEC said, “INSIGHTEC is at the forefront of the global shift towards non-invasive procedures. Ultimately, our goal is to transform medical practices as we know them today and to improve patient outcomes, reduce morbidity and trauma while reducing costs. Health Canada’s regulatory approval of our Exablate Neuro technology is an important milestone in our path to fulfilling our mission,” said Dr. Ferré.
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.