Doctors across the globe are now using INSIGHTEC’s Exablate Neuro Model 4000 system to treat more than 1,000 patients for essential tremor and to conduct research, a record number for the MR-guided focused ultrasound treatment.
The treatment is currently administered at 30 medical centers in 10 countries with 80 percent of patients suffering from ET who did not respond to medication prescribed for the condition. The other 20 percent underwent treatment for research purposes.
“The standard of care is medication, however, it is estimated that ~40% are refractory to medications … given the immediate reduction patients see in their tremor, the heightened quality of patient care, and the potential reduced costs to the health care system, we hope to see focused ultrasound adopted as the new standard of care for essential tremor,” Maurice Ferre, the CEO and chairman of INSIGHTEC, told HCB News.
The milestone follows the one year anniversary of the FDA’s approval of Exablate Neuro in July 2016
for use with 3.0T MR systems, and indicates an increased interest in the use of focused ultrasound treatments, much of which was generated by regulatory approval in the U.S., Europe, South Korea, Canada, Israel and Japan. The FDA also approved the device in May for use with 1.5 MR systems.
The device differs from other treatments, such as surgery, in that it is noninvasive and reduces risks, such as infection, bleeding and recovery time, and allows patients to quickly resume their lives.
Aside from ET, the technology is also devised to be CE-marked for treating tremors in Parkinson’s disease patient and neuropathic pain. INSIGHTEC is hoping that further research of Exablate Neuro will introduce focused ultrasound as a treatment for other areas of health.
“The company is also working to expand the indications of focused ultrasound in the brain, including neurodegenerative diseases like Parkinson’s disease, epilepsy, OCD, and depression,” said Ferre. “In parallel, we are in the early development of focused ultrasound technology that can disrupt the blood-brain barrier. This development is monumental, as it holds the potential to deliver targeted drug therapies for various brain diseases.”
INSIGHTEC hopes to increase the number of facilities that Exablate Neuro is used in so that fewer people will have to travel for treatment, and hopes to expand coverage to reduce the burden of cost.
“As the benefits of the treatment become more well known, we expect more hospitals to invest in the technology,” said Ferre. “Our other primary objective is to have this treatment covered by CMS and private health care payers. Many patients are paying for this procedure out-of-pocket, so it’s imperative for the treatment to be accessible to all essential tremor patients. Essential tremor impacts people of all ages who want to maintain an active lifestyle.”