Insightec announced that its incision-free brain “surgery” technology — called Exablate 4000 (Exablate Neuro) — has been approved in China to treat essential tremor and tremors caused by Parkinson’s disease.
The market approval from China’s regulatory agency for medicines and medical devices, the National Medical Products Administration, will allow the technique’s use for patients who do not respond to standard therapies for Parkinson’s tremor.
“We are committed to improving the quality of life of patients in China and worldwide with impactful therapeutic treatments,” Maurice Ferré, MD, chairman and CEO at Insightec, said in a press release. “This achievement reflects positive momentum to bring Focused Ultrasound to movement disorder patients in China.”
The technique, called MR-guided focused ultrasound, uses magnetic resonance imaging (MRI) to first identify the brain tissue responsible for tremor. It then uses high-intensity focused ultrasound energy to precisely heat and ablate, or gradually remove, a deep brain target without the need for surgical incision or anesthesia.
Importantly, it is reported to do this without damaging nearby brain tissue.
“There are millions of people in China living with diminished function due to hand tremors from Essential Tremor and Tremor-dominant Parkinson’s disease” said Peng Qiu, Insightec China’s country manager.
Roughly 70% of people with Parkinson’s experience tremors during the initial stages of the disease, causing uncontrollable and involuntary muscle movements.
Traditionally, Parkinsonian tremors are treated with either medications or with a surgical procedure called deep brain stimulation. That technique involves implanting a device to stimulate targeted regions of the brain with electrical impulses generated by a battery-operated neurostimulator.
As the MR-guided focused ultrasound technique requires no surgical incisions or anesthesia, the treatment is expected to carry a lower risk. Additionally, follow-up appointments could take place virtually.
“Our elderly communities will now have an option that uses highly advanced technology that is less invasive,” Qiu said.
Exablate Neuro already is being used by nearly 60 neurosurgeons in treatment centers worldwide to regularly treat patients with hand tremors.
The treatment is performed in a single session. According to the company, many patients experience immediate tremor relief, with minimal side effects, and are able to return home the same day.
The technology also has received marketing approval from the U.S. Food and Drug Administration (FDA), as well as from other regulatory agencies in Argentina, Australia, Canada, Chile, Europe, Israel, Japan, Kazakhstan, Korea, Russia, Taiwan, and Turkey.
Insightec’s Exablate Body system is used in 20 hospitals across China to treat uterine fibroids.
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