NeuroOne Medical Technologies has announced the successful completion of an initial animal implant of its novel, thin-film paddle leads for spinal cord stimulation (SCS). The devices are intended for the treatment of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back and leg pain.
The study evaluated the feasibility of implanting a variety of sizes and shapes of ultra-thin paddle leads in a sheep model. A mini-laminectomy surgical approach was used to gain access to the epidural space for device placement, and all devices were “easily advanced” to the target location in less than one minute, a NeuroOne press release details.
A competitive silicone-based lead was also placed for comparative purposes. The NeuroOne lead fitted comfortably in the epidural space and the veterinary surgeon reported no concerns regarding the placement of the lead.
According to the company, these results demonstrated feasibility for placement of a thin-film paddle lead intended to treat chronic back pain due to multiple failed back surgeries. More testing will now be completed to optimise the design and placement.
NeuroOne is also developing a percutaneous paddle lead placement system that would eliminate the need for an incision in the patient’s back. The preliminary benchtop testing for this percutaneous approach has also been successfully completed, the company claims.