The firm obtained US Food and Drug Administration (FDA) approval for its technology in 2016, based on a clinical study of 76 patients, which demonstrated that the treatment is effective and safe. A three-year follow-up of the same group of patients showed that tremor reduction was sustained over a period of three years, the company said.
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Essential tremor, a neurological disorder that commonly has a hereditary nature, affects more than 41 million people around the world and is thought to originate from the Vim nucleus of the thalamus — a part of the brain responsible for coordinating and controlling muscle activity, the Israeli company said.
An illustrative image of a patient with Parkinson’s disease (Obencem; iStock by Getty Images)
Parkinson’s disease also causes uncontrolled movements but differs from Essential Tremor in the parts of the body affected by the disease — involving also legs and chin, the timing of the tremor, and other emerging conditions related to the disease like stiffness and motor slowness.
To reduce these symptoms, Insightec has developed a treatment called Neuravive, where a minimally invasive form of surgery — called stereotactic surgery, which can remove, stimulate or ablate (scarring or destruction of tissue to correct a malfunction) specific targets in the body — is practiced without incising the patients’ skull.
During a tour of the company’s headquarters in the Haifa area recently, Insightec’s VP of Marketing Xen Mendelsohn Aderka said that Neuravive-focused ultrasound is an incisionless treatment for Essential Tremor and Tremor-Dominant Parkinson’s Disease. It is performed using the company’s device, Exablate Neuro, which combines two technologies: high intensity ultrasound and magnetic resonance imaging (MRI). The tour at the company was held as part of MEDinIsrael 2019, a conference gathering together global digital health companies and experts.
The high-intensity focused ultrasound beams, that pass through skin, muscle, fat, and bone, are used to generate heat and ablate the Vim point, leading to an overall reduction of tremor, Aderka said.
Xen Mendelsohn Aderka, VP of marketing at Insightec (Courtesy)
This procedure is guided by MRI, used as the eyes of the treatment, to focus on the region with extreme precision in order to prevent healthy adjacent tissue from being burnt, while at the same time monitoring the thermal variation in the area in question, she explained.
On treatment day, the patient’s scalp is shaved and cleaned completely so as to avoid any deflection of the energy from the targeted point during the procedure. Patients lie on the treatment bed inside the imaging scanner, and a helmet-like frame, that emits the beams — is placed by the surgeon in the right position. The targeted area is identified several days before the treatment via a CT scan to detail the shape, density and thickness of the skull.
Then, preliminary MRI images are taken to identify the precise location of the Vim point. Prior to the actual treatment, low — gradually increasing — energy sound-waves are directed towards this area to adjust the focal point and verify the target position’s accuracy.
