CEO Ori Hadomi told MassDevice.com today that the new brain module is an option on the Renaissance system that can be added to existing installations or purchased along with a new device.
"We extended our market offering to the brain because we see there is great synergy between these 2 markets [brain and spine]," Hadomi told us. "When you put it together with the fact that many neurosurgeons are doing both spine and brain, it made a lot sense for us to offer to hospitals another application where the technology can be used. What we are doing is really expanding the capabilities of the technology to offer more services and more applications within the spine and the brain. We aim to own this market, we want to lead it and stay the leader in this market. We believe there is so much more to do in this market."
The Renaissance brain module, slated to launch at the American Assn. of Neurological Surgeons annual meeting April 7, uses "a small, frameless platform with only 3 points of fixation to provide highly accurate access to the areas of the brain where intervention is needed," according to a press release.
Mazor said the Renaissance device was used for the 1st time earlier this month in a deep-brain stimulation procedure on a sleeping, 65-year-old patient with Parkinson’s disease.
"Most of the surgeons are doing these procedures when the patient is awake," Hadomi told us. "Here, because of the precision and because of the other abilities the system brings to the table, the surgeon has found it very beneficial to use it in the asleep procedure."
"DBS is among one of the most effective treatments for Parkinson’s," said Dr. David VanSickle of the Denver DBS Center, who performed the 1st asleep procedure at Littleton Adventist Hospital in Littleton, Colo. "New research recently published in the New England Journal of Medicine shows that undergoing DBS in the earlier stages of Parkinson’s disease is extremely effective, contrary to earlier recommendations that patients must have the disease for at least 7 years to see the benefits of DBS. The research also found DBS to be more effective than medications in controlling tremors in patients with Parkinson’s disease."
Mazor claims that the Renaissance system is the only mechanical guidance system cleared by the FDA for use in both spine and brain surgeries.