Breakthrough designation for stimulation device
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The company GTX medical has reached a great step forward: the US Food and Drug Administration (FDA) has granted a breakthrough device designation for its Go-2 implantable system. By decreasing the number of administrative hurdles, the access to the market could be speeded up. The system provides a so-called Targeted Epidural Spinal Stimulation (TESS) therapy, meant to promote the recovery of motor functions and neurological control in adults with spinal cord injuries.
For many years, Professor Grégoire Courtine and his team in Lausanne, Switzerland, have studied and developed technologies to improve recovery after spinal cord injury. The Wings for Life Foundation has been a long-time supporter of this technology.
The therapy consists of a paddle lead with 16 electrodes that is surgically put on the spinal cord at the region that controls leg movements. It is connected to a neurostimulator - a small pacemaker for the spinal cord - that is also implanted via a small incision. This procedure is practiced routinely in people with chronic pain. The Go-2 system facilitates reconnection of the brain with paralyzed leg muscles following spinal injury using electrical stimulation. Thus, intact but silent pathways in the spinal cord are activated to control movement of the lower limbs.
The company is still working out further details, but parameters for first trials with the new systems are already clear. Trials are planned to be conducted in centers located both in the U.S. and Europe. The Go-2 trial should include around 60 to 80 implants over the different premarket studies, starting in 2021. Market approval is expected to happen around 2024.
More details can be found on the GTX medical homepage.