Neurovascular bioelectronics medicine company Synchron has received breakthrough device designation for Stentrode interventional neuromodulation platform from the US FDA.
This fully implantable medical device is designed to translate brain activity or stimulate the nervous system from the inside of a blood vessel, without open brain surgery.
In addition to neuromodulation, Stentrode is also said to work as a neuroprosthesis device.
It has already been implanted in patients with upper-limb paralysis. The device is now being evaluated for its ability to provide functional independence in patients with paralysis through control of digital devices through thought alone.
Synchron CEO Thomas Oxley said: “As this is a first-of-its-kind device, we look forward to working closely with the FDA to prioritise development of the Stentrode and ensure access for patients with paralysis, as well as lay the groundwork for future indications for brain-computer interfaces.”
Stentrode is said to enable patients to train their brains to wirelessly control external systems without the need for using their hands or voice.
It is said to be the only investigational, implantable device that does not require open brain surgery while other neural interface devices need implantation through surgery.
According to the company, pre-clinical studies of the device have shown its long-term safety and its ability to pick up certain electrical frequencies emitted by the brain.
The company expects to finalise the protocol for a pivotal FDA-enabling study using safety and efficacy data from a currently active first-in-human clinical trial of Stentrode.
Upcoming research will analyse the use of the device in patients with paralysis due to spinal cord injury, ALS, stroke and muscular dystrophy, it said.
In a separate development, the FDA granted 510(k) clearance to B Braun Medical’s SpaceStation MRI to enable Spaceinfusion pumps to continuously provide medications to patients within the MRI suite.
The SpaceStation MRI protects the MR scanner and offers interference-free images by shielding Space infusion pumps against 1.5-T and 3.0-T magnetic fields.
It allows the transition of patients into the imaging suite with the SpaceStation MRI without the need for long infusion lines.
Braun Medical Marketing for Infusion Systems director Jonathan Stapley said: “This clearance allows us to expand our infusion therapy portfolio by providing seamless infusion management across multiple care settings.
“Our Space Infusion System allows standardisation of large volume and syringe pumps on the same workflow with one integration.”