Approvals

Medical device company Neuspera Medical has announced that it has received US Food and Drug Administration (FDA) approval for its implantable system, used to treat peripheral nerve pain.

The Neuspera system comprises of a first-of-its-kind, leadless micro-implant, wearable transmitter and digital information trackers ‒ including an app for smartphones and an iPad-based clinician programmer. The ultra-miniaturised implant uses peripheral nerve stimulation (PNS), a growing treatment option for managing chronic pain conditions.

Being 75 times smaller than the smallest commercial implantable pulse generator, it is hoped the Neuspera system will allow for better procedural flexibility through its ability to gain access to deeper anatomical targets.

Neuspera’s pipeline also includes the Nuvella system, a potential treatment for overactive bladder. In June 2022, phase 2 of the SANS-UUI clinical trial ‒ looking to evaluate the system’s safety and efficacy ‒ was announced.

Steffen Hovard, CEO of Neuspera Medical stated, “We look forward to bringing this innovative technology to physicians and patients in the US. The Neuspera ultra-miniaturised system has the potential to revolutionise the way physicians treat patients battling chronic pain while restoring patients’ health and quality of life.”