Sam Brusco, Associate Editor07.25.22
Endovascular brain-computer interface company Synchron has achieved the first human BCI implant in the U.S. According to the company, it’s the first to occur in the U.S. using an endovascular BCI approach, which doesn’t require open-brain surgery.
The procedure was performed at Mount Sinai West in New York, led by clinical investigator Shahram Majidi, MD, assistant professor of neurosurgery, neurology, and radiology at the Icahn School of Medicine at Mount Sinai.
This was the first U.S. patient implant in Synchron’s COMMAND trial, the first FDA IDE trial to assess a permanently implanted BCI. The study is evaluating the motor BCI platform, including the Stentrode, in severe paralysis patients. The goal is to enable the patient to control digital devices hands-free.
Study outcomes include use of brain data to control digital devices and achieve functional independence improvements.
“This is an incredibly exciting milestone for the field, because of its implications and huge potential,” Dr. Majidi told the press. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery."
“We are beyond excited to get to work with our patient, guiding them through the training process as they learn to use this device to live more independently and, most importantly, communicate with their family and friends,” said David Putrino, Ph.D., PT, Director of Rehabilitation Innovation for the Mount Sinai Health System and a Principal Investigator of the COMMAND study.
“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,” added Tom Oxley, MD, Ph.D., CEO and founder of Synchron. “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.”
Once implanted in the brain’s motor cortex via the jugular vein, Stentrode detects and wirelessly transmits motor intent via digital language so severely paralyzed patients can control personal devices with hands-free point-and-click. The trial will evaluate impact on everyday tasks like texting, emailing, online shopping, and accessing telehealth services, as well as the ability to live independently.
Synchron earned breakthrough status in August 2020.
The procedure was performed at Mount Sinai West in New York, led by clinical investigator Shahram Majidi, MD, assistant professor of neurosurgery, neurology, and radiology at the Icahn School of Medicine at Mount Sinai.
This was the first U.S. patient implant in Synchron’s COMMAND trial, the first FDA IDE trial to assess a permanently implanted BCI. The study is evaluating the motor BCI platform, including the Stentrode, in severe paralysis patients. The goal is to enable the patient to control digital devices hands-free.
Study outcomes include use of brain data to control digital devices and achieve functional independence improvements.
“This is an incredibly exciting milestone for the field, because of its implications and huge potential,” Dr. Majidi told the press. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery."
“We are beyond excited to get to work with our patient, guiding them through the training process as they learn to use this device to live more independently and, most importantly, communicate with their family and friends,” said David Putrino, Ph.D., PT, Director of Rehabilitation Innovation for the Mount Sinai Health System and a Principal Investigator of the COMMAND study.
“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,” added Tom Oxley, MD, Ph.D., CEO and founder of Synchron. “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.”
Once implanted in the brain’s motor cortex via the jugular vein, Stentrode detects and wirelessly transmits motor intent via digital language so severely paralyzed patients can control personal devices with hands-free point-and-click. The trial will evaluate impact on everyday tasks like texting, emailing, online shopping, and accessing telehealth services, as well as the ability to live independently.
Synchron earned breakthrough status in August 2020.