The U.S. Food and Drug Administration (FDA) has granted neurovascular bioelectronics medicine company Synchron Breakthrough Device designation for Stentrode, an implantable medical device that can translate brain activity or stimulate the nervous system from the inside of a blood vessel, without the need for open brain surgery.
The device, which has already been implanted in patients with upper-limb paralysis, is currently being evaluated for its ability to enable patients with paralysis to regain functional independence by control of digital devices through thought alone. The Breakthrough Devices Program is designed to expedite the development and FDA review of innovative solutions for more effective treatment of irreversibly debilitating diseases or conditions, among other purposes, and will lower the burden required for Medicare reimbursement.
“As this is a first-of-its-kind device, we look forward to working
closely with the FDA to prioritize development of the Stentrode and
ensure access for patients with paralysis, as well as lay the groundwork
for future indications for brain-computer interfaces,” said Thomas
Oxley, MD, PhD, CEO of Synchron.
Designed so that patients can train their brains to wirelessly control
external systems without the need for using their hands or voice, the
Stentrode is the only investigational, implantable device, that does not
require open brain surgery. Other neural interface devices, such as
those being developed by Elon Musk’s Neuralink and BrainGate, currently require drilling into the skull, and direct puncture into the brain, to achieve device implantation.
Safety and efficacy data from a currently-active first-in-human clinical
trial will be used to finalize the protocol for a pivotal FDA-enabling
study that will guide evaluation for U.S. marketing approval. Future
research will evaluate the use of the Stentrode in patients with
paralysis due to spinal cord injury, ALS, stroke and muscular dystrophy.
Pre-clinical studies have demonstrated the Stentrode’s long-term safety
as well as its ability to pick up specific electrical frequencies
emitted by the brain. Synchron, in collaboration with the University of
Melbourne, has published their scientific results in top ranking
journals including Nature Biotechnology, Nature Biomedical Engineering and the Journal of Neurosurgery.
Similar to the procedure utilized for implantation of cardiac
pacemakers, implantation of the Stentrode is a minimally-invasive
procedure during which the device is delivered to the brain through
blood vessels. As the Stentrode system is small and flexible enough to
safely pass through curving blood vessels, insertion of the device does
not require open brain surgery. This may reduce risk of brain tissue
rejection of the device, which has been a significant problem for other
techniques.
The technology relies on a revolutionary brain-controlled handsfree app
platform called brainOS™ to translate the brain activity into a
standardized digital language, directly through thought, to control apps
that restore communication and limb function. In addition, brainPort™, a
fully-internalized, wireless solution implanted in the chest provides
high-resolution neural data transmission, and is the final component of
the Synchron system.
