The procedure, performed at Mount Sinai West in New York, represents the first such implant to occur in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery.
Dr. Shahram Majidi, assistant professor of neurosurgery, neurology and radiology at the Icahn School of Medicine at Mount Sinai, led the procedure, which was performed in the angiography suite with a minimally invasive, endovascular approach. Earlier this year, Synchron’s neuroscience chief explained how this type of catheter delivery could enable better brain implants.
It was the first patient implant in Synchron’s Command trial, operating under FDA investigational device exemption to assess a permanently implanted BCI. Command will assess the safety and efficacy of the company’s motor BCI technology, including the Stentrode, in patients with severe paralysis, aiming to enable the patient to control digital devices hands-free. Study outcomes include the use of brain data to control digital devices and achieve improvements in functional independence, according to a news release.
“This is an incredibly exciting milestone for the field, because of its implications and huge potential,” Majidi said in the release. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery.”
Notably, the first-in-human implant pulls Synchron ahead of Elon Musk’s Neuralink, which is working to develop an implant placed in the brain through a robot-assisted procedure.
Neuralink requires implantation through the skull, and, while Musk and company officials said they planned to file for FDA approval for human trials in 2020, it has yet to receive such approval. Earlier this year, Neuralink and the University of California, Davis, were accused of “egregious violations of the Animal Welfare Act” by the Physicians Committee for Responsible Medicine (PCRM), citing documents obtained through a public records lawsuit. The allegations claimed that Neuralink caused extreme suffering in monkeys.
Synchron’s Stentrode is implanted within the major cortex through the jugular vein in a minimally invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent using a proprietary digital language to allow severely paralyzed patients to control personal devices with hands-free point-and-click.
The company intends to continue enrollment in the Command trial, while recently reported long-term safety results demonstrated the safe use of the device in four patients out to 12 months in an Australia-based trial.
“The first-in-human implant of an endovascular BCI in the U.S. is a major clinical milestone that opens up new possibilities for patients with paralysis,” Synchron CEO and founder Dr. Tom Oxley said. “Our technology is for the millions of people who have lost the ability to use their hands to control digital devices. We’re excited to advance a scalable BCI solution to market, one that has the potential to transform so many lives.”