Insightec has announced the CE-mark approval and European launch of Exablate Prime, which the company describes as a “significant enhancement” to its Exablate Neuro platform—a magnetic resonance imaging (MRI)-guided neurosurgery system that uses focused ultrasound to treat medication-refractory essential tremor and Parkinson’s disease.
Based on customer input and feedback, Exablate Prime is the culmination of more than 10 years of significant research and development designed to increase precision and efficiency, as per an Insightec press release. Like its predecessor, Exablate Prime enables incisionless neurosurgery as an outpatient procedure to provide relief to people living with movement disorders, such as essential tremor and Parkinson’s disease. According to Insightec, new improvements include an enriched user interface and enhancements to optimise productivity.
More specifically, these improvements include: an intuitive user interface; automated calculations; intuitive and informative therapy delivery; increased specificity and control; real-time monitoring; enhanced planning and support, and improved visualisation and image management. The system also boasts an optional, upgraded 3T head coil for improved imaging and 3D thermal spot visualisation.
“Our unwavering commitment to enhancing patient care through innovative technology led us to develop Exablate Prime,” said Maurice Ferre, chief executive officer and chairman of the board at Insightec. “Although Exablate Neuro has revolutionised the field of neurosurgery, Exablate Prime takes it to entirely new levels, pushing the boundaries of what is possible. We couldn’t be more proud of the end result—Exablate Prime is the future of incisionless neurosurgery.”
“With the growing number of European countries supporting focused ultrasound as a viable treatment option for essential tremor, Exablate Prime is truly exciting,” added Giuseppe Carbone, vice president of Insightec Europe. “We are confident it will make even more of a positive impact to empower Europeans living with essential tremor and Parkinson’s disease, as well as their physicians.”
Insightec claims that, to ensure Exablate Prime met the needs of working neurosurgeons, it was tested first in Rambam Hospital in Haifa, Israel, where suggestions for improvement were implemented. It was then tested by Oregon Health and Science University in Portland, USA.
“We were proud to lead the validation pilot study for Prime and be a design partner with Insightec,” said Lior Lev Tov (Rambam Hospital, Haifa, Israel). “We truly appreciate the great improvements it brings to the treatment.”
With this recent launch, Exablate Prime is now available for sale in both the USA and Europe, according to Insightec.