A startup company in Israel unveiled a revolutionary surgical procedure earlier this year that requires no incisions (cutting) to stop involuntary muscle tremors associated with certain neurological diseases.
Insightec developed a non-invasive way to treat uncontrollable shaking caused by Parkinson’s disease, which affects different parts of the body, and Essential Tremor, which makes the head, hand, and voice tremble. The innovative treatment was approved by the U.S. Food and Drug Administration (FDA) in 2016 and 2018.
The company’s vision “is to transform healthcare by making incisionless MR-guided focused ultrasound (MRgFUS) a standard of care for patients.”
Surgeons at the Rambam Hospital in Haifa performed the first successful operation that used ultrasound waves for deep brain stimulation. The landmark event coincided with the annual conference International Society for Therapeutic Ultrasound (ISTU) held in Barcelona from June 13-15, 2019.
The Exablate Neuro device from Insightec combines two technologies to halt disease-related tremors: high-intensity ultrasound (called Neuravive-focused ultrasound) and magnetic resonance imaging (MRI). The surgical tool is a computer mouse rather than a scalpel.
The Neuravive-focused ultrasound beams pass through skin, muscle, fat, and bone, generating heat and ablating (removing or destroying) the Vim (ventral intermediate nucleus of the thalamus) point. This reduces overall tremoring.
The MRI functions as the surgeon’s eyes, providing an extremely precise focus on the target region deep within the sensitive and complex cerebral mass. The surgeon uses a computer-guided system to monitor temperature changes and prevent adjacent tissue from being burnt away.
Several days before the bloodless treatment, the patient has a CT scan to map the shape, density, and thickness of the skull. The surgeon uses the CT scan image to find the proper treatment target deep inside the patient’s brain.
Before the operation, the patient’s scalp is shaved and thoroughly cleansed to prevent any of the directed energy to deflect from the target area. The treatment bed is located inside the MRI machine. The surgeon positions a helmet-like frame that emits beams.
Preliminary MRI images zero-in on the Vim point. Before beginning the actual treatment, low energy sound waves that are increased gradually are aimed toward the Vim area help the surgeon fine-tune the focal point and confirm that the target position is accurate.
The patient receives no anesthesia and is, therefore, able to provide immediate feedback to the surgeon and avoid unintended negative side effects. A tickling sensation in specific areas can signal where to direct the ultrasound waves. The surgeon might ask the patient to perform selected tasks such as drawing circles on a board to verify that the ultrasound waves are positioned accurately.
After the Neuravive-focused ultrasound waves have been calibrated precisely, the energy powering the device is increased to raise the temperature at the target site, causing permanent lesions of the targeted tissues. To protect the patient’s skull from overheating, tubes attached to the treatment bed’s frame circulate cold water continually.
Insightec’s software system provides real-time temperature readings in the area under treatment and is the “brains” behind the system’s targeting mechanism.
Upon completion, a post-operative MRI scan is used to check the ablated area. The entire operation lasts two to three hours. One hour after the procedure, the patient is able to leave the hospital – without tremors.
Because the operation requires no slicing open of skin or exposed tissues, there are very few post-op complications associated with invasive surgeries such as infection and collateral tissue damage. Recovery is rapid.
Patients have reported some moderate, short-term side effects from the new ultrasound anti-tremor treatment, including tingling in the fingers and tongue and losing the sense of balance. These symptoms generally disappear after one or two months.
Xen Mendelsohn Aderka, VP of Marketing for Insightec, indicated that the Exablate Neuro is being used in over 50 medical centers around the world and has treated over 2,000 neuro-patients.
Currently, Insightec has no competition for its focused ultrasound incisionless brain surgery. Traditional treatments involve medication and deep brain stimulation.
Founded in 1999, Insightec is headquartered in Tirat Carmel, Israel, and has global offices in Dallas, Texas, Miami, Florida, and Tokyo and Shanghai, Japan. Start-Up Nation Central compiles data to track Israeli technology firms and reported that the company has raised $307 million.
Insightec has won multiple international awards for technology innovation, including the 2018 Edison Award and the 2018 Fast Company award for the Israeli sector.