FDA grants breakthrough device designation for implanted spinal stimulation system

The Food and Drug Administration has granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature. The FDA designation aims to speed development and assessment of devices that promise a more effective treatment or diagnosis for a life-threatening or irreversibly debilitating conditions.

The company, based in Eindhoven, Netherlands, and Lausanne, Switzerland, plans to start the first clinical trial for TESS in 2021. Gtx expects to begin a clinical trial for its wearable Lift System later this year. The first generation of the technology for the Lift System, which delivers noninvasive electrical spinal stimulation therapy to improve or restore upper limb and hand function, received breakthrough device designation in 2017.

You can learn more about this latest breakthrough HERE.