The US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Stentrode, an implantable medical device designed to translate brain activity or stimulate the nervous system from the inside of a blood vessel, without the need for open brain surgery, Synchron announces in a media release.
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.
“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.”
— Thomas Oxley, MD, PhD, CEO of Synchron
No Brain Surgery Required
Designed so that patients can train their brains to wirelessly control external systems without the need to use their hands or voice, the Stentrode is reportedly the only investigational, implantable device that does not require open brain surgery. Rather, it is delivered to the brain through blood vessels.
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 US 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 journals including Nature Biotechnology, Nature Biomedical Engineering and the Journal of Neurosurgery.
The technology relies on a brain-controlled, hands-free 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, the release explains.
[Source(s): Synchron Inc, Business Wire]
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